Identity
- Device Name
- IM-50 PEDIATRIC BITEGUARD WITH STRAP EUDAMED
- Model / Reference
- IM-50 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05902596226305 EUDAMED
- Basic UDI-DI
- B-05902596226305 EUDAMED
- EMDN Code
- G030804 GASTROINTESTINAL ENDOSCOPY AND ECHOENDOSCOPY, BITE BLOCKS EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Poland EUDAMED
Clinical & Handling
Sterile
No
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
Im-50 Pediatric Biteguard With Strap by Inoris Medical Sp. Z O.o. — 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-05902596226305 | Class I | Active |
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Manufacturer
- Manufacturer
- Inoris Medical Sp. Z O.o.
- EUDAMED SRN
- PL-MF-000016864
Sources (1)
- EUDAMED fbdaf3ef-f0a1-4baf-bd0a-87d70a25f5c8 61 fields · synced Jul 23, 2026