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Bite Block 66Fr with Oxygen Connection
EUDAMEDFDA UDIClass I (EU MDR)
Ref GAR044
Identity
- Trade Name
- Bite Block 66Fr with Oxygen Connection EUDAMEDandorate® Bite Block 66Fr with Oxygen Connection FDA UDI
- Generic Name
- Endoscopic bite block, basic, single-use FDA UDI
- Device Name
- Bite Block EUDAMED
- Model / Reference
- GAR044 EUDAMEDFDA UDI
Identifiers
- Primary DI / UDI-DI
- 04897106953554 EUDAMEDFDA UDI
- Basic UDI-DI
- 489710695SDPC02095N EUDAMED
- FDA Product Code
- MNK FDA UDI
- EMDN Code
- G030804 GASTROINTESTINAL ENDOSCOPY AND ECHOENDOSCOPY, BITE BLOCKS EUDAMED
- GMDN Term
- Endoscopic bite block, basic, single-use FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 876.1500 FDA UDI
- Market of Registration
- Ireland 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
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
Prescription Use
Yes
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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Bite Block 66Fr with Oxygen Connection by Ga Health Company Limited — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 489710695SDPC02095N | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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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 (2)
- EUDAMED 7e8a28d5-9f35-4e55-9147-a7ac8a621c55 61 fields · synced Jul 10, 2026
- FDA UDI 2707b8f3-2d53-48dd-a121-a147416b4e8e 32 fields · synced May 30, 2026