Identity
- Device Name
- Intubation stylet EUDAMED
- Model / Reference
- IS101 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06942458001380 EUDAMED
- Basic UDI-DI
- B-06942458001380 EUDAMED
- EMDN Code
- R018004 INTUBATION DEVICE GUIDES EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- France 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
Intubation stylet by Integral Medical Products Co., Ltd. — Class I — 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-06942458001380 | Class I | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Integral Medical Products Co., Ltd.
- EUDAMED SRN
- CN-MF-000009217
- Authorised Representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Sources (1)
- EUDAMED 0dc5d072-710e-44e1-8b3e-d8101523c231 61 fields · synced Jun 18, 2026