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Single-use Sterile High-pressure Angiographic Syringes and Accessories
EUDAMEDClass IIa (EU MDR)
Ref HS-DCD201Model Type II: 25/60ml , 50/50ml, 50/100ml, 50/200ml, 60/60ml, 60/100ml, 60/200ml, 65/65ml, 65/115ml, 100/100ml, 100/200ml, 115/115ml, 125/125ml，130/200ml, 200/200ml, 65/200ml.Model 200/200 mL
Identity
- Trade Name
- Single-use Sterile High-pressure Angiographic Syringes and Accessories EUDAMEDSterile High-pressure Angiographic Syringes for Single-use EUDAMED
- Device Name
- Single-use Sterile High-pressure Angiographic Syringes and Accessories EUDAMEDSterile High-pressure Angiographic Syringes for Single-use EUDAMED
- Model / Reference
- Type II: 25/60ml , 50/50ml, 50/100ml, 50/200ml, 60/60ml, 60/100ml, 60/200ml, 65/65ml, 65/115ml, 100/100ml, 100/200ml, 115/115ml, 125/125ml，130/200ml, 200/200ml, 65/200ml. EUDAMEDHS-DCD201 EUDAMED200/200 mL EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06938327909178 EUDAMED
- Basic UDI-DI
- 69383279206XK EUDAMEDB-06938327909178 EUDAMED
- EMDN Code
- A02010401 SYRINGES FOR CONTRAST MEDIA INJECTOR, SINGLE-USE EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- France EUDAMEDSpain 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 — MDD, MDR — listed in EUDAMED
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Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDD
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | 69383279206XK | Class IIa | Active |
| EUDAMED | European Union | CE/MDR | 69383279206XK | 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 (2)
- EUDAMED ed556711-46fc-4441-a6a7-248aa271104b 61 fields · synced Oct 6, 2026
- EUDAMED 7ca1f999-e74f-4607-8ff2-92cddb194604 61 fields · synced May 18, 2026