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Sterile Oropharyngeal airway(Hollow oropharynx)
EUDAMEDClass IIa (EU MDR)
Ref HY-013-3 /3#
Identity
- Trade Name
- Sterile Oropharyngeal airway(Hollow oropharynx) EUDAMED
- Device Name
- Sterile Oropharyngeal airway EUDAMED
- Model / Reference
- HY-013-3 /3# EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06975834950408 EUDAMED
- Basic UDI-DI
- 697583495ZK8C EUDAMED
- EMDN Code
- R010102 GUEDEL AIRWAY TUBES EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Germany 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
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Sterile Oropharyngeal airway(Hollow oropharynx) by Ningbo Hanyue Medical Technology CO., LTD. — Class IIa — MDR — listed in EUDAMED
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 | 697583495ZK8C | Class IIa | Active |
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Manufacturer
- Manufacturer
- Ningbo Hanyue Medical Technology CO., LTD.
- EUDAMED SRN
- CN-MF-000035941
- Authorised Representative
- MedPath GmbH DE-AR-000000087
Sources (1)
- EUDAMED 460d8c5d-722a-466b-bfba-54bc659d92d1 61 fields · synced Oct 6, 2026