Identity
- Device Name
- Laryngeal Mask Introducer EUDAMED
- Model / Reference
- INT304 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06970675351605 EUDAMED
- Basic UDI-DI
- 697067535IMP2ASNNNSINT029 EUDAMEDB-06970675351605 EUDAMED
- EMDN Code
- R010280 LARYNGEAL MASKS AND TUBES - ACCESSORIES EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Germany EUDAMEDIreland 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
Laryngeal Mask Introducer by Integral Medical Products Co., Ltd. — Class IIa — MDD, MDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDD
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | 697067535IMP2ASNNNSINT029 | Class IIa | Active |
| EUDAMED | European Union | CE/MDR | 697067535IMP2ASNNNSINT029 | 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 a71dff1e-f250-46fd-b7a9-6a9cbb06e77e 61 fields · synced Jul 10, 2026
- EUDAMED 0a6d21bd-5c14-4579-9e8a-ac809072b9e9 61 fields · synced Jul 9, 2026