Identity
- Device Name
- Dose-control Syringes EUDAMED
- Model / Reference
- BM-DCS-12 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06958481494921 EUDAMED
- Basic UDI-DI
- B-06958481494921 EUDAMED695848140026M9 EUDAMED
- EMDN Code
- A02010401 SYRINGES FOR CONTRAST MEDIA INJECTOR, SINGLE-USE EUDAMEDA02010499 SYRINGES FOR INJECTOR, SINGLE-USE - OTHER EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Netherlands EUDAMED
Clinical & Handling
Sterile
Yes
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
Category: Angiography kit
Dose-control Syringes by BrosMed Medical Co., Ltd. — Class I — MDR, MDD — listed in EUDAMED — regulatory data on deviCERTS
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Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | B-06958481494921 | Class I | Active |
| EUDAMED | European Union | CE/MDD | B-06958481494921 | Class I | Active |
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Manufacturer
- Manufacturer
- BrosMed Medical Co., Ltd
- EUDAMED SRN
- CN-MF-000007501
- Authorised Representative
- Brosmed Medical B.V. NL-AR-000002616
Sources (2)
- EUDAMED 28b40370-face-4c4b-bc01-74d8cc73c301 61 fields · synced Jun 18, 2026
- EUDAMED 1720031e-a900-4c43-bd48-ffbf1c37bf78 61 fields · synced May 17, 2026