Identity
- Trade Name
- Bouffant cap blue 21" EUDAMED
- Device Name
- Bouffant cap for single use EUDAMED
- Model / Reference
- Bouffant cap EUDAMEDCHC01 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08586006512508 EUDAMED
- Basic UDI-DI
- 858601504BOUFFANTCAP255N EUDAMED
- Direct Marketing DI
- 08586006512508 EUDAMED
- EMDN Code
- T0207 CAPS AND HEADWEAR (EXCLUDING PERSONAL PROTECTIVE EQUIPMENT - PPE) 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
Bouffant cap blue 21" 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 | 858601504BOUFFANTCAP255N | Class I | Active |
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Manufacturer
- Manufacturer
- CHIRANA T.Injecta, a.s.
- EUDAMED SRN
- SK-MF-000003702
Sources (1)
- EUDAMED c7f46c1d-5c7d-4a8c-a92c-77a2c28aff52 61 fields · synced Jul 22, 2026