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Laryngeal Masks
EUDAMEDClass IIa (EU MDR)
Ref 91080010Model Silicon Laryngeal Mask:2#Ref 91080002Model PVC Laryngeal Mask: 1.5#Ref 91080013Model Silicone Laryngeal Mask:4#Ref 91080012Model Silicone Laryngeal Mask:3#Ref 91080014Model Silicone Laryngeal Mask:5#Ref 91080005Model PVC Laryngeal Mask: 3#Ref 91080003Model PVC Laryngeal Mask:2#
Identity
- Trade Name
- LARYNGEAL MASKS EUDAMED
- Device Name
- Laryngeal Mask EUDAMED
- Model / Reference
- Silicon Laryngeal Mask:2# EUDAMED91080010 EUDAMEDPVC Laryngeal Mask: 1.5# EUDAMED91080002 EUDAMEDSilicone Laryngeal Mask:4# EUDAMED91080013 EUDAMEDSilicone Laryngeal Mask:3# EUDAMED91080012 EUDAMEDSilicone Laryngeal Mask:5# EUDAMED91080014 EUDAMEDPVC Laryngeal Mask: 3# EUDAMED91080005 EUDAMEDPVC Laryngeal Mask:2# EUDAMED91080003 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06972745360890 EUDAMED06972745360814 EUDAMED06972745361224 EUDAMED06972745361217 EUDAMED06972745360869 EUDAMED06972745360845 EUDAMED06972745360821 EUDAMED06972745360852 EUDAMED06972745361231 EUDAMED
- Basic UDI-DI
- B-06972745360890 EUDAMEDB-06972745360814 EUDAMEDB-06972745361224 EUDAMEDB-06972745361217 EUDAMEDB-06972745360869 EUDAMEDB-06972745360845 EUDAMEDB-06972745360821 EUDAMEDB-06972745360852 EUDAMEDB-06972745361231 EUDAMED
- EMDN Code
- R01020101 LARYNGEAL MASKS, SINGLE-LUMEN EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Finland EUDAMEDIreland EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMED
Implantable
No
EUDAMEDEUDAMED
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
EUDAMEDEUDAMED
Measuring Function
No
EUDAMEDEUDAMED
Incorporates Medicinal Product
No
EUDAMED
Laryngeal Masks 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-06972745360890 | 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 (9)
- EUDAMED 14ebb05d-154d-4fbb-898b-0f0e7546cdeb 61 fields · synced Sep 18, 2026
- EUDAMED 297dc311-8948-4a0e-b6b6-79338a5d71d5 61 fields · synced May 16, 2026
- EUDAMED 208d2e25-3576-4a03-9d74-2f563db70ce2 61 fields · synced May 17, 2026
- EUDAMED 5462cbee-dbc8-4bbf-a605-904c06b2bbae 61 fields · synced May 17, 2026
- EUDAMED e0162a19-1f64-4139-b9c9-631734c3f149 61 fields · synced May 17, 2026
- EUDAMED 4093b379-0a7c-413b-8683-fe80b24c9717 61 fields · synced May 18, 2026
- EUDAMED cc85e9cf-b57f-4ea7-8aac-064adb0b43d8 61 fields · synced May 18, 2026
- EUDAMED a2e7c691-ece1-49ac-9dc2-5dea4ce2b993 61 fields · synced May 19, 2026
- EUDAMED b8e3fe02-bc6c-40cb-b00e-9391549bf42a 61 fields · synced May 19, 2026