Identity
- Trade Name
- ScopeGuard Plus Protect Bite Block EUDAMED
- Device Name
- Bite Block EUDAMED
- Model / Reference
- ENDO0209 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04897106955220 EUDAMED
- Basic UDI-DI
- 489710695SDPC02095N EUDAMED
- EMDN Code
- G030804 GASTROINTESTINAL ENDOSCOPY AND ECHOENDOSCOPY, BITE BLOCKS EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Ireland 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
ScopeGuard Plus Protect Bite Block by Ga Health Company Limited — 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 | 489710695SDPC02095N | Class I | Active |
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Manufacturer
- Manufacturer
- GA Health Company Limited
- EUDAMED SRN
- HK-MF-000019784
- Authorised Representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Sources (1)
- EUDAMED 7e1d4789-b924-4aff-9374-6ef0b1649ee2 61 fields · synced Jun 18, 2026