Identity
- Trade Name
- Foliodress Mask Loop Typ IIR EUDAMED
- Device Name
- Medical Face Mask EUDAMED
- Model / Reference
- NS2R-02 EUDAMED992479 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06955356117909 EUDAMED06955356190278 EUDAMED06955356111433 EUDAMED06955356111129 EUDAMED
- Basic UDI-DI
- 69553561MASKAV6 EUDAMED
- Direct Marketing DI
- 06955356190278 EUDAMED
- EMDN Code
- T020604 MEDICAL USE FACE MASKS, TYPE II AND IIR EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Italy EUDAMEDGermany 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
Foliodress Mask Loop Typ IIR by Gemtier Medical (Shanghai) Inc. — Class I — 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 | 69553561MASKAV6 | Class I | Active |
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Manufacturer
- Manufacturer
- Gemtier Medical (Shanghai) Inc.
- EUDAMED SRN
- CN-MF-000003835
- Authorised Representative
- CMC Medical Devices & Drugs SL ES-AR-000000293
Sources (4)
- EUDAMED 6763dc0e-8f10-45ea-b05f-3f9db619726f 61 fields · synced Jul 24, 2026
- EUDAMED 18e724d9-5367-4f84-b7b2-93d478051c12 61 fields · synced May 11, 2026
- EUDAMED 58616fdd-6272-4cd8-acfd-b4111c252c63 61 fields · synced May 19, 2026
- EUDAMED 6fb72156-5e87-4719-9e20-211a39de9eee 61 fields · synced May 19, 2026