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Silicone Laryngeal Mask Airway
EUDAMEDClass IIa (EU MDR)
Ref LM1507S2Model LM1004S2
Identity
- Device Name
- Silicone Laryngeal Mask Airway EUDAMED
- Model / Reference
- LM1507S2 EUDAMEDLM1004S2 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06970675350172 EUDAMED
- Basic UDI-DI
- B-06970675350172 EUDAMED697067535IMP2ASNNNSLM00XD EUDAMED
- EMDN Code
- R01020101 LARYNGEAL MASKS, SINGLE-LUMEN EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Ireland 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
Silicone Laryngeal Mask Airway by Integral Medical Products Co., Ltd. — Class IIa — MDR, MDD — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | B-06970675350172 | Class IIa | Active |
| EUDAMED | European Union | CE/MDD | B-06970675350172 | Class IIa | Active |
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Manufacturer
- Manufacturer
- Integral Medical Products Co., Ltd.
- EUDAMED SRN
- CN-MF-000009217
- Authorised Representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Sources (2)
- EUDAMED 58c9a18c-49d0-4c4f-9bc7-f5f8b3341912 61 fields · synced Jun 18, 2026
- EUDAMED 6e50edb4-936b-440d-8114-f8d7853c55aa 61 fields · synced Jun 18, 2026