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Bt-Da22w
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref BT-DMF-006Model BT-DA24-IA, BT-DB24-IA, BT-DA22-IA, BT-DB22-IA, BT-DA22W, BT-DB22W
Identity
- Trade Name
- BT-DA22W EUDAMEDBSD3543W Digital Flat Panel X-ray Detector FDA UDI
- Generic Name
- Indirect flat panel x-ray detector FDA UDI
- Model / Reference
- BT-DA24-IA, BT-DB24-IA, BT-DA22-IA, BT-DB22-IA, BT-DA22W, BT-DB22W EUDAMEDBT-DMF-006 EUDAMEDBT-DA22W FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08800069500051 EUDAMEDFDA UDI
- Basic UDI-DI
- 880006950CG2422WWV EUDAMED
- Direct Marketing DI
- 08800069500051 EUDAMED
- FDA Product Code
- MQB FDA UDI
- EMDN Code
- Z11030599 RADIOLOGY INSTRUMENTS - OTHER EUDAMED
- GMDN Term
- Indirect flat panel x-ray detector FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 892.1680 FDA UDI
- Market of Registration
- Poland EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
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
Yes
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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Bt-Da22w by BONTECH Co., Ltd. — Class IIa — 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 | 880006950CG2422WWV | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- BONTECH Co., Ltd.
- EUDAMED SRN
- KR-MF-000048185
- Authorised Representative
- CMC Medical Devices & Drugs SL ES-AR-000000293
Sources (2)
- EUDAMED 816f524c-ea67-4190-bb9e-8c3500bf9286 61 fields · synced Jun 17, 2026
- FDA UDI 1ec4091c-63a0-4ae3-bbc5-3f35a6da93f1 32 fields · synced May 26, 2026