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Berman Airway
EUDAMEDClass I (EU MDR)
Ref 1110207Ref 1110206Ref 1111204Ref 1111207Ref 1110211
Identity
- Trade Name
- Berman Airway EUDAMED
- Device Name
- Oropharyngeal Airway EUDAMED
- Model / Reference
- 1110207 EUDAMED1110206 EUDAMED1111204 EUDAMED1111207 EUDAMED1110211 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04719871892879 EUDAMED04719871892855 EUDAMED04719871892978 EUDAMED04719871893036 EUDAMED04719871892954 EUDAMED
- Basic UDI-DI
- 471987189FM1XD0400DX EUDAMED
- EMDN Code
- R010102 GUEDEL AIRWAY TUBES 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
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
Berman Airway 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 | 471987189FM1XD0400DX | 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 29454dc1-0b44-4e7c-b4c8-40419b085924 61 fields · synced Jul 31, 2026
- EUDAMED 0a622fcc-de2d-453d-8e3c-43be0cfbc816 61 fields · synced May 17, 2026
- EUDAMED 583dfaff-d170-42d8-99b5-25bba9e929f0 61 fields · synced May 17, 2026
- EUDAMED 4a9dcbba-b0e6-4d47-9767-677621e76c1b 61 fields · synced May 17, 2026
- EUDAMED c1cf2183-3bfd-499a-a485-48106ecfb2ec 61 fields · synced May 18, 2026