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Soft Guedel Airway
EUDAMEDClass I (EU MDR)
Ref 1110408Ref 1110406Ref 1110403Ref 1110409
Identity
- Trade Name
- Soft Guedel Airway EUDAMED
- Device Name
- Oropharyngeal Airway EUDAMED
- Model / Reference
- 1110408 EUDAMED1110406 EUDAMED1110403 EUDAMED1110409 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04719871893692 EUDAMED04719871893654 EUDAMED04719871893593 EUDAMED04719871893715 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
Soft 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 dc189bd5-9120-44c8-a8a0-7f6ef6c0bf4b 61 fields · synced Jul 24, 2026
- EUDAMED b24e3de0-555f-49f8-8d99-ecaa4efa15fb 61 fields · synced May 18, 2026
- EUDAMED b87b4fc2-5b6a-4bea-9c03-dd36a9e54e1b 61 fields · synced May 18, 2026
- EUDAMED ec0544d1-baf4-46bb-bf14-2741b4753efd 61 fields · synced May 19, 2026