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Harness (Medium/Small) for CPAP Face Mask
EUDAMEDClass I (EU MDR)
Ref 2223000Ref 1220112-01Ref 1220102Ref 1220101Ref 1220113-01
Identity
- Trade Name
- Harness (Medium/Small) for CPAP Face Mask EUDAMED
- Device Name
- Harness EUDAMED
- Model / Reference
- 2223000 EUDAMED1220112-01 EUDAMED1220102 EUDAMED1220101 EUDAMED1220113-01 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04719871891766 EUDAMED04719871894293 EUDAMED04719871893906 EUDAMED04719871893890 EUDAMED04719871894309 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
Harness (Medium/Small) for CPAP Face Mask 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 (5)
- EUDAMED b1809cf2-3d88-4664-bf8f-e60e4009f0e6 61 fields · synced Aug 1, 2026
- EUDAMED 4feaaaf5-636f-48cc-b34a-bb7f120f896c 61 fields · synced May 16, 2026
- EUDAMED 805aee62-f298-47f7-884c-07d30480603d 61 fields · synced May 17, 2026
- EUDAMED ba8b0f14-5ae1-4371-bf92-a857cdf619d6 61 fields · synced May 18, 2026
- EUDAMED 55a75733-3f9c-4cbb-9034-9c684325bfcd 61 fields · synced May 18, 2026