Identity
- Device Name
- IM 65 ADULT BITEGUARD SOFT EUDAMED
- Model / Reference
- IM 65 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05902596226398 EUDAMED
- Basic UDI-DI
- B-05902596226398 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 65 Adult Biteguard Soft 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-05902596226398 | Class I | Active |
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Manufacturer
- Manufacturer
- Inoris Medical Sp. Z O.o.
- EUDAMED SRN
- PL-MF-000016864
Sources (1)
- EUDAMED dc397590-0de7-4097-9ba8-0c0e603578a2 61 fields · synced Jul 12, 2026