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Disposable Oropharyngeal Airway
EUDAMEDClass I (EU MDR)
Ref KY-12Ref KY-5Ref KY-10Ref KY-9Ref KY-6Ref KY-4
Identity
- Trade Name
- Disposable Oropharyngeal Airway EUDAMED
- Device Name
- Disposable Oropharyngeal Airway EUDAMED
- Model / Reference
- KY-12 EUDAMEDKY-5 EUDAMEDKY-10 EUDAMEDKY-9 EUDAMEDKY-6 EUDAMEDKY-4 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06944375391452 EUDAMED06944375391384 EUDAMED06944375391438 EUDAMED06944375391421 EUDAMED06944375391391 EUDAMED06944375391377 EUDAMED
- Basic UDI-DI
- B-06944375391452 EUDAMEDB-06944375391384 EUDAMEDB-06944375391438 EUDAMEDB-06944375391421 EUDAMEDB-06944375391391 EUDAMEDB-06944375391377 EUDAMED
- EMDN Code
- R010102 GUEDEL AIRWAY TUBES EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Czechia EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Disposable Oropharyngeal Airway by Zhejiang Haisheng Medical Device Co., Ltd. — Class I — MDD — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-06944375391452 | Class I | Active |
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Manufacturer
- Manufacturer
- Zhejiang Haisheng Medical Device Co., Ltd.
- EUDAMED SRN
- CN-MF-000026345
- Authorised Representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Sources (6)
- EUDAMED 1a8ee9a7-2687-4a07-a7a7-081db020d1b7 61 fields · synced Jul 29, 2026
- EUDAMED c703d543-45fd-40f8-9cfb-1fdd70145f6e 61 fields · synced May 16, 2026
- EUDAMED d11c6ba4-8318-40e7-94d7-ce40a75e9ce7 61 fields · synced May 17, 2026
- EUDAMED 6d80362f-695c-4423-a46a-5a85787148c1 61 fields · synced May 18, 2026
- EUDAMED fec1ef0b-3dea-4f81-8e38-9f17c1bdcf03 61 fields · synced May 18, 2026
- EUDAMED 6c7c10d7-b45e-4b2d-8e4a-c5347cf13877 61 fields · synced May 19, 2026