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Sterile High-pressure Angiographic Syringes for Multi-use
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref MHS-DCD201Model 200/200ml 24hRef MHS-NC200Model 200ml 24hRef MHS-NC100Model 100mL 24hRef MHS-DC201Ref MHS-ICD200Ref MHS-GMD65Model 65/65mL 24hRef MHS-NCD200Ref MHS-BC200Ref HS-NCD100Model 100/100mL 24hRef MHS-GMD265Model 65/200mL 24hRef MHS-MMD65TRef 241828
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 EUDAMED24h CT 200ml Syringe(Orange) FDA UDI
- Model / Reference
- 200/200ml 24h EUDAMEDMHS-DCD201 EUDAMED200ml 24h EUDAMEDMHS-NC200 EUDAMED100mL 24h EUDAMEDMHS-NC100 EUDAMEDMHS-DC201 EUDAMEDMHS-ICD200 EUDAMED65/65mL 24h EUDAMEDMHS-GMD65 EUDAMEDMHS-NCD200 EUDAMEDMHS-BC200 EUDAMED100/100mL 24h EUDAMEDHS-NCD100 EUDAMED65/200mL 24h EUDAMEDMHS-GMD265 EUDAMEDMHS-MMD65T EUDAMED241828 EUDAMED372401 FDA UDI
- Description
- 24h CT 200ml Syringe(Orange) FDA UDI
Identifiers
- Catalog Number
- 241828 FDA UDI
- Primary DI / UDI-DI
- 06938327909260 EUDAMED06938327909376 EUDAMED06938327909352 EUDAMED06938327909253 EUDAMED06938327909321 EUDAMED06938327909291 EUDAMED06938327909383 EUDAMED06938327909222 EUDAMED06938327909369 EUDAMED06938327909307 EUDAMED06938327909338 EUDAMED06938327906917 EUDAMEDFDA UDI
- Basic UDI-DI
- 69383279202XB EUDAMED69383279201X9 EUDAMED69383279227XT EUDAMED69383279234XQ EUDAMED69383279228XV EUDAMED69383279235XS 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 | 69383279202XB | 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 (13)
- EUDAMED 092b2902-76cf-4d06-9098-8080b683118e 61 fields · synced Oct 6, 2026
- EUDAMED 686e92a8-e504-454c-bbca-5624354d05a5 61 fields · synced May 11, 2026
- EUDAMED 4527e16b-309c-4364-859e-726226268427 61 fields · synced May 16, 2026
- EUDAMED c1414e04-0c90-4e8e-bd37-01b0ebdaa510 61 fields · synced May 16, 2026
- EUDAMED 1de864af-5b72-429c-bd63-081ae1f0749c 61 fields · synced May 17, 2026
- EUDAMED 7f567c79-f96a-4358-8a6c-e0dfcc445179 61 fields · synced May 17, 2026
- EUDAMED e9650d05-0ce0-402f-bc92-94cfb5ce55e7 61 fields · synced May 17, 2026
- EUDAMED 47e8da53-caf7-45a4-83e5-f9ceea65d662 61 fields · synced May 17, 2026
- EUDAMED 873ff758-5b92-449b-812b-2763a7f48cdb 61 fields · synced May 18, 2026
- EUDAMED 275a2bdf-4bc7-41ea-8cb3-24145a39e764 61 fields · synced May 18, 2026
- EUDAMED e3d43223-cb7e-42c8-be16-50a6a4da427b 61 fields · synced May 18, 2026
- EUDAMED 7babe18b-707c-4b35-b797-4f96675f6612 61 fields · synced May 18, 2026
- FDA UDI 640c87b0-9fde-4ae1-8c9c-6aaf4d27f7c7 37 fields · synced May 30, 2026