← Back to catalogue
Full-face Masks
EUDAMEDClass IIa (EU MDR)
Ref FM-1LModel FM-1S, FM-1M, FM-1LRef FM-1SRef FM-1M
Identity
- Device Name
- Full-face Masks EUDAMED
- Model / Reference
- FM-1S, FM-1M, FM-1L EUDAMEDFM-1L EUDAMEDFM-1S EUDAMEDFM-1M EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06957469401845 EUDAMED06957469401821 EUDAMED06957469401838 EUDAMED
- Basic UDI-DI
- 6957469403002DZ EUDAMED
- EMDN Code
- R03010201 AIR/OXYGEN MASKS 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
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
Full-face Masks by Shenyang RMS Medical Tech Co., Ltd. — Class IIa — 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 | 6957469403002DZ | Class IIa | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Shenyang RMS Medical Tech Co., Ltd.
- EUDAMED SRN
- CN-MF-000023286
- Authorised Representative
- MedPath GmbH DE-AR-000000087
Sources (3)
- EUDAMED e05430bd-90c4-4314-ae3d-afa5a0eebea5 61 fields · synced Jul 14, 2026
- EUDAMED 7be6cafe-04ea-48c2-a16c-eea14e21959c 61 fields · synced May 17, 2026
- EUDAMED 5459ba0d-e01a-41f3-8ea2-67b96abf85fb 61 fields · synced May 18, 2026