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Sterile Laryngeal Masks(Silicone)
EUDAMEDClass IIa (EU MDR)
Ref HY-021-1 /1.0Ref HY- 021-2 /1.5Ref HY- 021-7 /5.0
Identity
- Trade Name
- Sterile Laryngeal Masks(Silicone) EUDAMED
- Device Name
- Sterile Laryngeal Masks EUDAMED
- Model / Reference
- HY-021-1 /1.0 EUDAMEDHY- 021-2 /1.5 EUDAMEDHY- 021-7 /5.0 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06975834951597 EUDAMED06975834951603 EUDAMED06975834951658 EUDAMED
- Basic UDI-DI
- 697583495HZ7L EUDAMED
- EMDN Code
- R01020101 LARYNGEAL MASKS, SINGLE-LUMEN 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 Laryngeal Masks(Silicone) by Ningbo Hanyue Medical Technology CO., LTD. — Class IIa — 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 | 697583495HZ7L | 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 (3)
- EUDAMED a0fe6a38-2421-49d4-8e16-39456ee34c5d 61 fields · synced Oct 6, 2026
- EUDAMED e5e4ce9a-fd85-4ca2-990d-69eea8b7f42a 61 fields · synced May 18, 2026
- EUDAMED a32a0a28-317f-4895-96da-28a23bc96d76 61 fields · synced May 19, 2026