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Sterile Oropharyngeal airway(Hollow oropharynx)
EUDAMEDClass IIa (EU MDR)
Ref HY-013-12 /12#Ref HY-013-8 /8#Ref HY-013-7 /7#Ref HY-013-6 /6#Ref HY-013-10 /10#Ref HY-013-9 /9#Ref HY-013-4 /4#Ref HY-013-11 /11#
Identity
- Trade Name
- Sterile Oropharyngeal airway(Hollow oropharynx) EUDAMED
- Device Name
- Sterile Oropharyngeal airway EUDAMED
- Model / Reference
- HY-013-12 /12# EUDAMEDHY-013-8 /8# EUDAMEDHY-013-7 /7# EUDAMEDHY-013-6 /6# EUDAMEDHY-013-10 /10# EUDAMEDHY-013-9 /9# EUDAMEDHY-013-4 /4# EUDAMEDHY-013-11 /11# EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06975834950392 EUDAMED06975834950354 EUDAMED06975834950347 EUDAMED06975834950330 EUDAMED06975834950378 EUDAMED06975834950361 EUDAMED06975834950316 EUDAMED06975834950385 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 (8)
- EUDAMED 19516365-2175-4485-b06f-d3cfb482f747 61 fields · synced Oct 6, 2026
- EUDAMED a99deea4-eff2-4804-97df-abb0fd872265 61 fields · synced May 16, 2026
- EUDAMED 38e99467-ed1e-4a9c-9950-203e9652f774 61 fields · synced May 18, 2026
- EUDAMED 771f8f46-0bd5-4c86-9ddd-89a1e5a227fe 61 fields · synced May 18, 2026
- EUDAMED a6868715-f758-40f9-b28a-5b72c8d8cc17 61 fields · synced May 18, 2026
- EUDAMED 488df500-e113-4b58-b9e7-c93bc5e35805 61 fields · synced May 18, 2026
- EUDAMED 32acd4e5-a11c-462c-82e6-2f14d4e443dc 61 fields · synced May 19, 2026
- EUDAMED ef4890f9-d02e-46ea-bfea-90f0725cf152 61 fields · synced May 19, 2026