Identity
- Trade Name
- Advanced Halo Chin Strap EUDAMED
- Device Name
- Chin Strap EUDAMED
- Model / Reference
- FMMD2064 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04719876361233 EUDAMED
- Basic UDI-DI
- 471987636FMDHEADGEAR7J EUDAMED
- EMDN Code
- R030180 RESPIRATORY MASKS - ACCESSORIES NOT INCLUDED IN OTHER CLASSES EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
Yes
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
Advanced Halo Chin Strap by Foxxmed Ltd — 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 | 471987636FMDHEADGEAR7J | Class I | Active |
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Manufacturer
- Manufacturer
- Foxxmed Ltd
- EUDAMED SRN
- TW-MF-000022145
- Authorised Representative
- Obelis s.a. BE-AR-000000106
Sources (1)
- EUDAMED 8d8a1eac-8358-4a85-a90f-8a8887b8a5ad 61 fields · synced Jul 29, 2026