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bite block
EUDAMEDClass I (EU MDR)
Ref GJ040-100Model GJ040-100 GJ041-100 GJ042-100 GJ042-200 GJ040-101 GJ041-101 GJ042-101 GJ042-201
Identity
- Device Name
- bite block EUDAMED
- Model / Reference
- GJ040-100 GJ041-100 GJ042-100 GJ042-200 GJ040-101 GJ041-101 GJ042-101 GJ042-201 EUDAMEDGJ040-100 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06974495710017 EUDAMED
- Basic UDI-DI
- 697449571BiteBlock001VE EUDAMED
- EMDN Code
- G030804 GASTROINTESTINAL ENDOSCOPY AND ECHOENDOSCOPY, BITE BLOCKS EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Austria EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
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 Yuyao Guangjing Medical Instrument Co., Ltd — 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 | 697449571BiteBlock001VE | Class I | Active |
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Manufacturer
- Manufacturer
- Yuyao Guangjing Medical Instrument Co., Ltd
- EUDAMED SRN
- CN-MF-000027689
- Authorised Representative
- SUNGO Europe B.V. NL-AR-000000247
Sources (1)
- EUDAMED e33f8835-ab12-49c7-9d35-33fde69b8c72 61 fields · synced Oct 6, 2026