Identity
- Trade Name
- Oxygen Therapy Torso Unit With Adhesive EUDAMED
- Device Name
- Oxygen Therapy Torso Unit With Adhesive EUDAMED
- Model / Reference
- O2TUC2026 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08809964140232 EUDAMED
- Basic UDI-DI
- 880996414O2TUC2026MV 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 Torso Unit With Adhesive 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 | 880996414O2TUC2026MV | 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 5224b25c-21d8-4a92-8bbf-8c1ccf62281f 61 fields · synced Jul 21, 2026