Identity
- Trade Name
- Oxygen Therapy Chamber Lower Extremity Boot EUDAMED
- Device Name
- Oxygen Therapy Chamber Lower Extremity Boot EUDAMED
- Model / Reference
- O2TEC1 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08809964140218 EUDAMED
- Basic UDI-DI
- 880996414O2TEC1MW EUDAMED
- EMDN Code
- R03010207 OXYGEN THERAPY KITS EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Oxygen Therapy Chamber Lower Extremity Boot by GHC Co., Ltd. — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 880996414O2TEC1MW | Class I | Active |
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Manufacturer
- Manufacturer
- GHC Co., Ltd.
- EUDAMED SRN
- KR-MF-000043303
- Authorised Representative
- Caretechion GmbH DE-AR-000005946
Sources (1)
- EUDAMED 197768ae-3da0-466a-bd5e-4df53d68df2c 61 fields · synced Jun 19, 2026