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R01020101
EUDAMEDClass IIa (EU MDR)
Ref 91080008Model Silicone Laryngeal Mask:1.0#
Identity
- Trade Name
- R01020101 EUDAMED
- Device Name
- Laryngeal Mask EUDAMED
- Model / Reference
- Silicone Laryngeal Mask:1.0# EUDAMED91080008 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06972745360876 EUDAMED
- Basic UDI-DI
- B-06972745360876 EUDAMED
- EMDN Code
- R01020101 LARYNGEAL MASKS, SINGLE-LUMEN EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Finland 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
R01020101 by Guangzhou Orcl Medical Co., Ltd. — Class IIa — 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-06972745360876 | Class IIa | Active |
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Manufacturer
- Manufacturer
- Guangzhou Orcl Medical Co., Ltd.
- EUDAMED SRN
- CN-MF-000039222
- Authorised Representative
- Wellkang Ltd XI-AR-000001836
Sources (1)
- EUDAMED 8d850645-f110-48a2-a3d8-fba65ac4b64e 61 fields · synced Jul 14, 2026