Identity
- Trade Name
- Disposable Oropharyngeal Airway EUDAMED
- Device Name
- Disposable Oropharyngeal Airway EUDAMED
- Model / Reference
- KY-8 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06944375391414 EUDAMED
- Basic UDI-DI
- B-06944375391414 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-06944375391414 | 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 (1)
- EUDAMED 8eade45e-73fd-4a2c-9db0-0b578ca2d4f3 61 fields · synced Jun 18, 2026