Identity
- Trade Name
- Bite Block EUDAMED
- Device Name
- Bite Block EUDAMED
- Model / Reference
- U600005 EUDAMEDU600006 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05420051302475 EUDAMED05420051302482 EUDAMED
- Basic UDI-DI
- 54200513-TF18-BBL-SU-9N EUDAMED
- EMDN Code
- G030804 GASTROINTESTINAL ENDOSCOPY AND ECHOENDOSCOPY, BITE BLOCKS EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Belgium EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
Yes
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
Bite Block by G-Flex Flexible Instruments Europe — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 54200513-TF18-BBL-SU-9N | Class I | Active |
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Manufacturer
- Manufacturer
- G-Flex Flexible Instruments Europe
- EUDAMED SRN
- BE-MF-000000623
Sources (2)
- EUDAMED d10a085d-0413-40db-be53-313c18bb0e02 61 fields · synced Jul 24, 2026
- EUDAMED 08487d01-973c-414b-a32f-eb97ac9bd4e2 61 fields · synced May 18, 2026