Identity
- Trade Name
- Disposable Anesthetic masks EUDAMED
- Device Name
- Disposable Anesthetic masks EUDAMED
- Model / Reference
- CRR516AM EUDAMED
Identifiers
- Primary DI / UDI-DI
- 26970487104172 EUDAMED
- Basic UDI-DI
- B-26970487104172 EUDAMED
- EMDN Code
- R03010101 ANAESTHETIC FACE MASKS 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
Category: Anaesthesia face mask, single-use
Disposable Anesthetic masks by Shaoxing Carere Medical Appliance Co., Ltd. — Class IIa — MDD — listed in EUDAMED — regulatory data on deviCERTS
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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-26970487104172 | 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 6567b687-fd2d-4de4-a6b2-bd6d32c22318 61 fields · synced Jun 19, 2026