Identity
- Trade Name
- Slit Guedel Airway, ISO 10,100mm EUDAMED
- Device Name
- Oropharyngeal Airway EUDAMED
- Model / Reference
- 124450-000100 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04719871891032 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
Slit Guedel Airway, ISO 10, 100mm 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 (1)
- EUDAMED 363d2724-121c-48da-8b81-1737ac537e52 61 fields · synced Jun 18, 2026