Identity
- Trade Name
- COMFIKIDS BALACLAVA 5-14 YRS EUDAMED
- Device Name
- Elasticated Tubular Bandages and Garments (ComfiGarments) EUDAMED
- Model / Reference
- CC14 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05021209600605 EUDAMED
- Basic UDI-DI
- 5019829C01nT036G0BBG EUDAMED
- EMDN Code
- T0299 PROTECTION DRAPES AND GARMENTS - OTHER EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Ireland 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
Comfikids Balaclava 5-14 Yrs by Vernacare — 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 | 5019829C01nT036G0BBG | Class I | Active |
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Manufacturer
- Manufacturer
- Vernacare
- EUDAMED SRN
- GB-MF-000008063
- Authorised Representative
- Advena Limited MT-AR-000000234
Sources (1)
- EUDAMED ebc8cf96-34a0-44ee-b768-0ffcd54e1692 61 fields · synced Jul 8, 2026