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Sterile High-pressure Angiographic Syringes for Multi-use
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref 241826Model 200/200ml 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 200/200ml Syringes(Green) FDA UDI
- Model / Reference
- 200/200ml 12h EUDAMED241826 EUDAMED371202 FDA UDI
- Description
- 12h CT 200/200ml Syringes(Green) FDA UDI
Identifiers
- Catalog Number
- 241826 FDA UDI
- Primary DI / UDI-DI
- 06938327906924 EUDAMEDFDA UDI
- Basic UDI-DI
- 69383279212XE 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 | 69383279212XE | 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 d94a9712-34aa-4765-83cc-63a75bd7b6eb 61 fields · synced Jun 18, 2026
- FDA UDI b6d13129-3cec-414c-a0a1-f9f84b39f3c1 37 fields · synced May 30, 2026