Identity
- Trade Name
- Heuer EUDAMED
- Device Name
- Guedel Airway- 1 EUDAMED
- Model / Reference
- 14-100-04 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 89044078016928 EUDAMED
- Basic UDI-DI
- 890440781410004LM EUDAMED
- EMDN Code
- R010102 GUEDEL AIRWAY TUBES EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Austria EUDAMED
Clinical & Handling
Sterile
Yes
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
Yes
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Heuer by G.S.T. Corporation Limited — Class IIa — CE/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 | 890440781410004LM | Class IIa | Active |
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Manufacturer
- Manufacturer
- G.S.T. Corporation Limited
- EUDAMED SRN
- IN-MF-000040767
- Authorised Representative
- Obelis s.a. BE-AR-000000106
Sources (1)
- EUDAMED c8bbc262-a6f8-4bc4-96fc-aec3dee91c8e 61 fields · synced Oct 7, 2026