Identity
- Trade Name
- Disposable Oxygen masks EUDAMED
- Device Name
- Disposable Oxygen masks EUDAMED
- Model / Reference
- CRR632OM EUDAMED
Identifiers
- Primary DI / UDI-DI
- 26970487104516 EUDAMED
- Basic UDI-DI
- B-26970487104516 EUDAMED
- EMDN Code
- R0301020301 OXYGEN THERAPY STANDARD NASAL CANNULAS (GOGGLES) EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Poland EUDAMED
Clinical & Handling
Sterile
Yes
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
Disposable Oxygen masks by Shaoxing Carere Medical Appliance 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-26970487104516 | Class IIa | Active |
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Manufacturer
- Manufacturer
- Shaoxing Carere Medical Appliance Co., Ltd.
- EUDAMED SRN
- CN-MF-000025928
- Authorised Representative
- MedPath GmbH DE-AR-000000087
Sources (1)
- EUDAMED 466e6945-337f-4811-a5ba-ea3e82bf3243 61 fields · synced Oct 6, 2026