Identity
- Device Name
- Extension Sets EUDAMED
- Model / Reference
- Fama-06 EUDAMED
Identifiers
- Primary DI / UDI-DI
- D-Fama-06JM EUDAMED
- Basic UDI-DI
- B-Fama-06JM EUDAMED
- EMDN Code
- A03020199 EXTENSIONS - OTHER EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Türkiye EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Extension Sets by Bq Plus Medical Co., Ltd — Class IIa — MDD — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-Fama-06JM | Class IIa | Active |
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Manufacturer
- Manufacturer
- BQ Plus Medical Co., Ltd.
- EUDAMED SRN
- CN-MF-000010259
- Authorised Representative
- Prolinx GmbH DE-AR-000005129
Sources (1)
- EUDAMED d0af84fb-ab11-41e7-9dd9-98f6380a9288 61 fields · synced Jun 19, 2026