Identity
- Trade Name
- Face mask EAR LOOP EUDAMED
- Device Name
- Face mask for single use EUDAMED
- Model / Reference
- Face mask EUDAMEDCHFM02 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08586015042546 EUDAMED
- Basic UDI-DI
- 858601504FACEMASK25R5 EUDAMED
- Direct Marketing DI
- 08586015042546 EUDAMED
- EMDN Code
- T020604 MEDICAL USE FACE MASKS, TYPE II AND IIR EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Czechia 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
Face mask EAR LOOP by CHIRANA T.Injecta, a.s. — 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 | 858601504FACEMASK25R5 | Class I | Active |
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Manufacturer
- Manufacturer
- CHIRANA T.Injecta, a.s.
- EUDAMED SRN
- SK-MF-000003702
Sources (1)
- EUDAMED ea77363a-4410-4051-9920-a59ca48f8f74 61 fields · synced Jul 12, 2026