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Single-use Sterile High-pressure Angiographic Syringes and Accessories
EUDAMEDClass IIa (EU MDR)
Ref DRT-SK501FSModel Type II : 25ml, 50ml, 60ml, 65ml, 100ml, 115ml, 125ml, 130ml, 140ml, 150ml, 200ml
Identity
- Trade Name
- Single-use Sterile High-pressure Angiographic Syringes and Accessories EUDAMED
- Device Name
- Single-use Sterile High-pressure Angiographic Syringes and Accessories EUDAMED
- Model / Reference
- Type II : 25ml, 50ml, 60ml, 65ml, 100ml, 115ml, 125ml, 130ml, 140ml, 150ml, 200ml EUDAMEDDRT-SK501FS EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06938327901981 EUDAMED
- Basic UDI-DI
- 69383279204XF EUDAMED
- EMDN Code
- A02010401 SYRINGES FOR CONTRAST MEDIA INJECTOR, SINGLE-USE EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- France 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
Yes
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Category: Angiography kit
Single-use Sterile High-pressure Angiographic Syringes and Accessories by Shenzhen Boon Medical Supply Co., Ltd. — Class IIa — MDR — listed in EUDAMED
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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 | 69383279204XF | Class IIa | Active |
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Manufacturer
- Manufacturer
- Shenzhen Boon Medical Supply Co., Ltd.
- EUDAMED SRN
- CN-MF-000018400
- Authorised Representative
- Wellkang Ltd XI-AR-000001836
Sources (1)
- EUDAMED 7b7d33ec-1377-44f4-8cc0-977d9f54b940 61 fields · synced Jun 19, 2026