Identity
- Trade Name
- INORIS MEDICAL FDA UDI
- Generic Name
- Seizure bite block FDA UDI
- Device Name
- IM-60 ADULT BITEGUARD EUDAMED
- Model / Reference
- IM-60 EUDAMEDIM-60 Adult Biteguard FDA UDI
Identifiers
- Catalog Number
- IM-60 FDA UDI
- Primary DI / UDI-DI
- 05902596226367 EUDAMEDFDA UDI
- Basic UDI-DI
- B-05902596226367 EUDAMED
- FDA Product Code
- MNK FDA UDI
- EMDN Code
- G030804 GASTROINTESTINAL ENDOSCOPY AND ECHOENDOSCOPY, BITE BLOCKS EUDAMED
- GMDN Term
- Seizure bite block FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 876.1500 FDA UDI
- Market of Registration
- Poland EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
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
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Im-60 Adult Biteguard by Inoris Medical Sp. Z O.o. — Class I — MDD, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-05902596226367 | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Inoris Medical Sp. Z O.o.
- EUDAMED SRN
- PL-MF-000016864
Sources (2)
- EUDAMED fe8c4731-be99-48d5-b555-2f9613d88674 61 fields · synced Jul 27, 2026
- FDA UDI 506c679b-e72a-4e46-b7d3-6780adc1bd06 33 fields · synced May 30, 2026