Identity
- Trade Name
- MASK,PROC,IIR,HD EUDAMED
- Device Name
- Surgical Masks EUDAMED
- Model / Reference
- 17201 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08710685116393 EUDAMED
- Basic UDI-DI
- 8710685TF04001001QC EUDAMED
- EMDN Code
- T020604 MEDICAL USE FACE MASKS, TYPE II AND IIR EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Netherlands 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
Mask, Proc, Iir, Hd by Medica Europe B.V. — 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 | 8710685TF04001001QC | Class I | Active |
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Manufacturer
- Manufacturer
- Medica Europe B.V.
- EUDAMED SRN
- NL-MF-000000118
Sources (1)
- EUDAMED 4cefd824-d33d-46ca-a969-f3a57784d4d0 61 fields · synced Aug 4, 2026