← Back to catalogue
BT-DA12M, Pinkview-UPS
EUDAMEDClass IIa (EU MDR)
Ref BT-DMF-008Model BT-DA12M, Pinkview-UPS
Identity
- Trade Name
- BT-DA12M, Pinkview-UPS EUDAMED
- Model / Reference
- BT-DA12M, Pinkview-UPS EUDAMEDBT-DMF-008 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08800069500075 EUDAMED
- Basic UDI-DI
- 880006950CG0812VG EUDAMED
- Direct Marketing DI
- 08800069500075 EUDAMED
- EMDN Code
- Z11030599 RADIOLOGY INSTRUMENTS - OTHER EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Poland 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
Yes
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
BT-DA12M, Pinkview-UPS by BONTECH Co., Ltd. — Class IIa — 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 | 880006950CG0812VG | Class IIa | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- BONTECH Co., Ltd.
- EUDAMED SRN
- KR-MF-000048185
- Authorised Representative
- CMC Medical Devices & Drugs SL ES-AR-000000293
Sources (1)
- EUDAMED 611ca30d-eea5-4bfe-bd00-629142d0a12e 61 fields · synced Jun 18, 2026