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Sterile High-pressure Angiographic Syringes for Multi-use
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref 241825Model 200ml 12h
Identity
- Trade Name
- Sterile High-pressure Angiographic Syringes for Multi-use EUDAMEDGuerbet FDA UDI
- Generic Name
- Contrast medium injection system syringe FDA UDI
- Device Name
- Sterile High-pressure Angiographic Syringes for Multi-use EUDAMED12h CT 200ml Syringe(Green) FDA UDI
- Model / Reference
- 200ml 12h EUDAMED241825 EUDAMED371201 FDA UDI
- Description
- 12h CT 200ml Syringe(Green) FDA UDI
Identifiers
- Catalog Number
- 241825 FDA UDI
- Primary DI / UDI-DI
- 06938327906900 EUDAMEDFDA UDI
- Basic UDI-DI
- 69383279211XC EUDAMED
- 510(k) Number
- K241109 FDA UDI
- FDA Product Code
- DXT FDA UDI
- EMDN Code
- A0299 SYRINGES - OTHER EUDAMED
- GMDN Term
- Contrast medium injection system syringe FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 870.1650 FDA UDI
- Market of Registration
- France EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
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
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Sterile High-pressure Angiographic Syringes for Multi-use by Shenzhen Boon Medical Supply Co., Ltd. — Class IIa — MDR, FDA UDI — listed in EUDAMED, FDA GUDID
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 69383279211XC | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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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 b56c17c8-ddb2-41c0-898e-08113c12b8ac 61 fields · synced Jun 20, 2026
- FDA UDI d28b6c20-fbb9-4198-a946-c10ba3275f4d 37 fields · synced May 30, 2026