OxyRevo Australia — Certification & Compliance Register
Manufacturer: Zhuji Belecon Health Technology Co., Ltd · No.12 Jinjishan Road, Jiyang Street, Zhuji City, Zhejiang Province, China
1. CE Certificates & Verifications (ECM — Ente Certificazione Macchine)
| # | Document Type | Document / Cert No. | Product | Associated TCF / Test Report No. | Issuing Body | CE Directive(s) | Standards Verified | Issue Date | Expiry Date |
|---|---|---|---|---|---|---|---|---|---|
| 1 | CE Certificate | 0P230407.ZBHUW55 | Oil Free Air Compressor / Air Pump AE01–08, AP01–08, O2ILS14/15, O2ILH15/16/18/20 |
MD-TCF-230407-45790 TEZJ23040745791 |
Ente Certificazione Macchine (ECM), Italy | 2006/42/EC (Machinery) 2014/35/EU (Low Voltage) 2014/30/EU (EMC) |
EN ISO 12100:2010, EN 60204-1:2018, EN 1012-1:2010, EN IEC 61000-6-2:2019, EN IEC 61000-6-4:2019, EN IEC 61000-3-2:2019+A1:2021, EN 61000-3-3:2013+A2:2021 | 07 Apr 2023 | 06 Apr 2028 |
| 2 | CE Verification | 0P230407.ZBHUW53 | Stainless Steel Tank Quest 30–90 Pro, Space series, Delux Pod/Combo/Pro, O2ILH/M/Pro/Fly series |
TPZJ23040745788 | Ente Certificazione Macchine (ECM), Italy | 2014/68/EU (Pressure Equipment) | EN 12953-1:2012, EN 14222:2021 | 07 Apr 2023 | 06 Apr 2028 |
| 3 | CE Certificate | 0P230407.ZBHUW56 | Air Refrigerator Dryer (Dehumidifier) ZLA01–06, LQ01–06 |
MD-TCF-230407-45792 TEZJ23040745793 |
Ente Certificazione Macchine (ECM), Italy | 2006/42/EC (Machinery) 2014/35/EU (Low Voltage) 2014/30/EU (EMC) |
EN ISO 12100:2010, EN 60204-1:2018, EN IEC 61000-6-2:2019, EN IEC 61000-6-4:2019, EN IEC 61000-3-2:2019+A1:2021, EN 61000-3-3:2013+A2:2021 | 07 Apr 2023 | 06 Apr 2028 |
| 4 | CE Attestation | 0P230407.ZBHUW54 | Inflatable Bag Elite, Apex, Forward, Heal, Heal Multi, OXY, O2ILS series |
TGZJ23040745789 | Ente Certificazione Macchine (ECM), Italy | 2001/95/EC (General Product Safety) | EN ISO 23537-1:2016+A1:2018, EN ISO 23537-2:2016 | 07 Apr 2023 | 06 Apr 2028 |
2. UKCA Verifications of Conformity (ICR Polska)
| # | Document Type | Document / Cert No. | S/N | Product | Models | Issuing Body | UK Regulation(s) | Standards | Issue Date | Expiry Date |
|---|---|---|---|---|---|---|---|---|---|---|
| 5 | UKCA | ICR/VC/HM2503215 | 013434 | Air Dehumidifier | ZLA01–08, LQ01–08 | ICR Polska Co. Ltd. | Electrical Equipment (Safety) Regs 2016; EMC Regulations 2016 | BS EN IEC 60335-1:2023+A11:2023, BS EN IEC 55014-1:2021, EN IEC 55014-2:2021, BS EN IEC 61000-3-2:2019+A1:2021, BS EN 61000-3-3:2013+A2:2021 | 26 Mar 2025 | 25 Mar 2030 |
| 6 | UKCA | ICR/VC/HM2503216 | 013435 | Hyperbaric Chamber | Elite/Apex/28/32/36/40, Forward90, Heal40–90, Quest30–36, Space60–90, House H1–9, Silo S1–9, Relax R1–9, Monoplace/Multiplace/Pro/Pod/01–06, O2ILH/M/Pro/Fly75/80/86/90 | ICR Polska Co. Ltd. | Pressure Equipment (Safety) Regulations 2016 | BS EN 13445-1:2021 | 26 Mar 2025 | 25 Mar 2030 |
| 7 | UKCA | ICR/VC/HM2503217 | 013436 | Inflatable Bag | Elite/Apex/28/32/36/40, Forward90, Heal40–90 | ICR Polska Co. Ltd. | General Product Safety Regulations 2005 | BS EN ISO 23537-1:2022 | 26 Mar 2025 | 25 Mar 2030 |
| 8 | UKCA | ICR/VC/HM2503218 | 013437 | Oil Free Air Compressor / Air Pump | AE01–09, AP01–09, O2ILS14/15, O2ILH15/16/18/20 | ICR Polska Co. Ltd. | Supply of Machinery (Safety) Regulations 2008 | BS EN ISO 12100:2010, BS EN 60204-1:2018 | 26 Mar 2025 | 25 Mar 2030 |
| 9 | UKCA | ICR/VC/HM2503219 | 013438 | Rest Pod | Quest30–36, Space60–90, House H1–9, Silo S1–9, Relax R1–9, Monoplace/Multiplace/Pro/Pod/01–06, O2ILH/M/Pro/Fly75/80/86/90 | ICR Polska Co. Ltd. | Pressure Equipment (Safety) Regulations 2016 | BS EN 13445-1:2021 | 26 Mar 2025 | 25 Mar 2030 |
| 10 | UKCA | ICR/VC/HM2503220 | 013439 | Stainless Steel Tank | Quest30–36, Space60–90, House H1–9, Silo S1–9, Relax R1–9, Monoplace/Multiplace/Pro/Pod/01–06, O2ILH/M/Pro/Fly75/80/86/90 | ICR Polska Co. Ltd. | Pressure Equipment (Safety) Regulations 2016 | BS EN 13445-1:2021 | 26 Mar 2025 | 25 Mar 2030 |
3. ISO / Quality Management System Certificate
| # | Document Type | Certificate No. | Standard | Scope | Issuing Body | Issue Date | Registration Date | Expiry Date |
|---|---|---|---|---|---|---|---|---|
| 11 | ISO Certificate | AKAQMSMD000884 | ISO 13485:2016 | Sales of Hyperbaric Oxygen Chambers and Related Accessories | Jiangsu AKA International Standard Certification Co., Ltd. | 08 Dec 2023 | 07 Dec 2023 | 06 Dec 2026 |
4. Technical Construction Files (TCF) & MD/LVD Technical Reports
| # | Document Type | File / Report No. | Product | Models | Prepared By | Directive | Standards Covered | Date |
|---|---|---|---|---|---|---|---|---|
| 12 | TCF / MD+LVD | MD-TCF-230407-45790 | Oil Free Air Compressor / Air Pump | AE01–08, AP01–08, O2ILS14/15, O2ILH15/16/18/20 | Shanghai Global Testing Services (GTS) | 2006/42/EC Machinery; 2014/35/EU LVD | EN ISO 12100, EN 1012-1, EN 60204-1 | 06 Apr 2023 |
| 13 | TCF / MD+LVD | MD-TCF-230407-45792 | Air Refrigerator Dryer (Dehumidifier) | ZLA01–06, LQ01–06 | Shanghai Global Testing Services (GTS) | 2006/42/EC Machinery; 2014/35/EU LVD | EN ISO 12100, EN 60204-1 | 06 Apr 2023 |
| 14 | TCF | TGZJ23040745789 | Inflatable Bag | Elite, Apex, Forward, Heal, Heal Multi, OXY, O2ILS series | Shanghai Global Testing Services (GTS) | 2001/95/EC General Product Safety | EN ISO 23537-1:2016+A1:2018, EN ISO 23537-2:2016 | 06 Apr 2023 |
5. Risk Assessment Reports
| # | Document Type | File No. | Product | Models | Prepared By | Directive | Date |
|---|---|---|---|---|---|---|---|
| 15 | Risk Assessment | MD-TCF-230407-45790 | Oil Free Air Compressor / Air Pump | AE01–08, AP01–08, O2ILS14/15, O2ILH15/16/18/20 | Shanghai Global Testing Services (GTS) | 2006/42/EC Machinery Directive | 06 Apr 2023 |
| 16 | Risk Assessment | MD-TCF-230407-45792 (filed as MD-TCF-220510-38556) |
Air Refrigerator Dryer (Dehumidifier) | ZLA01–06, LQ01–06 | Shanghai Global Testing Services (GTS) | 2006/42/EC Machinery Directive | 06 Apr 2023 |
6. EMC Technical Files
| # | Document Type | File No. | Product | Models | Prepared By | Standards | Result | Date |
|---|---|---|---|---|---|---|---|---|
| 17 | EMC Report | TEZJ23040745791 | Oil Free Air Compressor / Air Pump | AE01–08, AP01–08, O2ILS14/15, O2ILH15/16/18/20 | Shanghai Global Testing Services (GTS) | EN IEC 61000-6-4:2019, EN IEC 61000-6-2:2019, EN IEC 61000-3-2:2019+A1:2021, EN 61000-3-3:2013+A2:2021 | PASS | 06 Apr 2023 |
| 18 | EMC Report | TEZJ23040745793 | Air Refrigerator Dryer | ZLA-01–06 | Shanghai Global Testing Services (GTS) | EN IEC 61000-6-4:2019, EN IEC 61000-6-2:2019, EN IEC 61000-3-2:2019+A1:2021, EN 61000-3-3:2013+A2:2021 | PASS | 06 Apr 2023 |
7. Material & Chemical Testing Reports (SGS)
| # | Document Type | Report No. | Sample / Material | Test Framework | Testing Lab | Sample Received | Report Date | Result |
|---|---|---|---|---|---|---|---|---|
| 19 | RoHS Test | SHAEC2110662211 | Mattress Sponge (Square Sponge / White Foam) | RoHS Directive (EU) 2015/863 amending Annex II to 2011/65/EU; IEC 62321 series | SGS-CSTC Standards Technical Services (Shanghai) Co., Ltd | 27 May 2021 | 01 Jun 2021 | PASS |
| 20 | SVHC / REACH | CZXHL23002411601 | Silicone Seal Strip (Grey soft plastic) | REACH — 235 SVHC Candidate List substances (ECHA, to Jun 2023); SVHC ≤ 0.1% w/w | SGS-CSTC Standards Technical Services (Changzhou) Co., Ltd | 27 Dec 2023 | 05 Jan 2024 | PASS |
| 21 | SVHC / REACH | CZXHL23002180601 | TPU Composite Fabric | REACH — 235 SVHC Candidate List substances (ECHA, to Jun 2023); SVHC ≤ 0.1% w/w | SGS-CSTC Standards Technical Services (Changzhou) Co., Ltd | 24 Nov 2023 | 04 Dec 2023 | PASS |
Notes:
1. All CE certificates were issued by Ente Certificazione Macchine (ECM, Italy) under a voluntary non-notified procedure in accordance with European Commission note of 14 September 2022 (Ares(2022)6342894). These documents support but do not replace the EC Declaration of Conformity.
2. All UKCA verifications were issued by ICR Polska Co. Ltd. on a voluntary basis. The UKCA mark may only be affixed by the manufacturer after satisfying all essential requirements of the relevant UK regulations.
1. All CE certificates were issued by Ente Certificazione Macchine (ECM, Italy) under a voluntary non-notified procedure in accordance with European Commission note of 14 September 2022 (Ares(2022)6342894). These documents support but do not replace the EC Declaration of Conformity.
2. All UKCA verifications were issued by ICR Polska Co. Ltd. on a voluntary basis. The UKCA mark may only be affixed by the manufacturer after satisfying all essential requirements of the relevant UK regulations.
