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CPAP harness for mask-M/L adult-bulk packed
EUDAMEDClass I (EU MDR)
Ref 2224001
Identity
- Trade Name
- CPAP harness for mask-M/L adult-bulk packed EUDAMED
- Device Name
- Harness EUDAMED
- Model / Reference
- 2224001 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04719871894316 EUDAMED
- Basic UDI-DI
- 471987189D5560AM EUDAMED
- EMDN Code
- R030180 RESPIRATORY MASKS - ACCESSORIES NOT INCLUDED IN OTHER CLASSES EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Lithuania 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
CPAP harness for mask-M/L adult-bulk packed by Foremount Enterprise Co., 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 | 471987189D5560AM | Class I | Active |
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Manufacturer
- Manufacturer
- Foremount Enterprise Co., Ltd.
- EUDAMED SRN
- TW-MF-000006734
- Authorised Representative
- Advena Limited MT-AR-000000234
Sources (1)
- EUDAMED cfd6bc31-8f4d-4a31-994b-aad8a8dc279e 61 fields · synced Jul 13, 2026