Identity
- Trade Name
- OC-E100 EUDAMED
- Device Name
- Oxygen Concentrator for Medical use EUDAMED
- Model / Reference
- OC-E100 EUDAMEDECQGOE-1 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06955623000194 EUDAMED
- Basic UDI-DI
- B-06955623000194 EUDAMED
- EMDN Code
- Z12159004 OXYGEN CONCENTRATORS EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Greece EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Oc-E100 by Sysmed (china) Co., Ltd — Class IIa — MDD — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-06955623000194 | Class IIa | Active |
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Manufacturer
- Manufacturer
- SysMed (China) Co., Ltd.
- EUDAMED SRN
- CN-MF-000011904
- Authorised Representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Sources (1)
- EUDAMED 2b0b9d2a-5f89-4179-8c18-2d9c38299c61 61 fields · synced Jun 18, 2026