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BM Silicone Laryngeal Mask Devices
EUDAMEDClass IIa (EU MDR)
Ref 231 02 00 2Model Silicone: 1#, 1.5#, 2#, 2.5#, 3#, 4#, 5#
Identity
- Trade Name
- BM Silicone Laryngeal Mask Devices EUDAMED
- Device Name
- Laryngeal Mask Devices EUDAMED
- Model / Reference
- Silicone: 1#, 1.5#, 2#, 2.5#, 3#, 4#, 5# EUDAMED231 02 00 2 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06942382610719 EUDAMED
- Basic UDI-DI
- 697209192LMDS16MU EUDAMED
- Direct Marketing DI
- 06942382610719 EUDAMED
- EMDN Code
- R01020101 LARYNGEAL MASKS, SINGLE-LUMEN EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Poland 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
BM Silicone Laryngeal Mask Devices by Bonree Medical 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 | 697209192LMDS16MU | Class IIa | Active |
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Manufacturer
- Manufacturer
- Bonree Medical Co., Ltd.
- EUDAMED SRN
- CN-MF-000017844
- Authorised Representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Sources (1)
- EUDAMED 8013b0b7-af13-4581-897b-33d0e298925c 61 fields · synced Jun 18, 2026