Identity
- Trade Name
- DCT EUDAMED
- Device Name
- oxygen mask EUDAMED
- Model / Reference
- / EUDAMEDH7 1191 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06974269381672 EUDAMED
- Basic UDI-DI
- B-06974269381672 EUDAMED
- EMDN Code
- R03010206 MASKS WITH RESERVOIR EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Germany 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
Dct by Zhejiang Baite Medical Appliances 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-06974269381672 | Class IIa | Active |
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Manufacturer
- Manufacturer
- Zhejiang Baite Medical Appliances Co., Ltd.
- EUDAMED SRN
- CN-MF-000021983
- Authorised Representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Sources (1)
- EUDAMED 6da9532b-e656-4c72-9cde-5e7c6303787b 61 fields · synced Jul 20, 2026