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Rigid Guedel Airway
EUDAMEDClass I (EU MDR)
Ref 1110305Ref 1110309Ref 1110303Ref 1110308
Identity
- Trade Name
- Rigid Guedel Airway EUDAMED
- Device Name
- Oropharyngeal Airway EUDAMED
- Model / Reference
- 1110305 EUDAMED1110309 EUDAMED1110303 EUDAMED1110308 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04719871893173 EUDAMED04719871893258 EUDAMED04719871893135 EUDAMED04719871893234 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
Rigid Guedel 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 (4)
- EUDAMED eeeb70ca-3578-4c65-aad6-bf1aac89b5b3 61 fields · synced Jul 26, 2026
- EUDAMED bde87c9d-8e05-478c-ac27-5865ac9be947 61 fields · synced May 16, 2026
- EUDAMED a9901264-c4ad-4ea0-8900-e6a74ae47bd6 61 fields · synced May 18, 2026
- EUDAMED cc99f419-a314-4062-a812-413706deec2f 61 fields · synced May 18, 2026