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Sterile High-pressure Angiographic Syringes for Single-use
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref 97-HS-TC200PLUSModel 200 mL
Identity
- Trade Name
- Sterile High-pressure Angiographic Syringes for Single-use EUDAMEDSpectraVue FDA UDI
- Generic Name
- Angiography kit FDA UDI
- Device Name
- Sterile High-pressure Angiographic Syringes for Single-use EUDAMED1-200 mL Syringe 1-Fill Straw & 1-Large Spike 1-72” Coiled Tubing FDA UDI
- Model / Reference
- 200 mL EUDAMED97-HS-TC200PLUS EUDAMED100104-P FDA UDI
- Description
- 1-200 mL Syringe 1-Fill Straw & 1-Large Spike 1-72” Coiled Tubing FDA UDI
Identifiers
- Catalog Number
- 97-HS-TC200PLUS FDA UDI
- Primary DI / UDI-DI
- 06938327901516 EUDAMEDFDA UDI
- Basic UDI-DI
- B-06938327901516 EUDAMED
- FDA Product Code
- DXT FDA UDI
- EMDN Code
- A02010401 SYRINGES FOR CONTRAST MEDIA INJECTOR, SINGLE-USE EUDAMED
- GMDN Term
- Angiography kit FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 870.1650 FDA UDI
- Market of Registration
- Spain 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
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
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
Category: Angiography kit
Sterile High-pressure Angiographic Syringes for Single-use by Shenzhen Boon Medical Supply Co., Ltd. — Class IIa — MDD, FDA UDI — listed in EUDAMED, FDA GUDID
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Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-06938327901516 | 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 a0423b11-1b88-4528-ba5a-5e78a8317fd9 61 fields · synced Oct 6, 2026
- FDA UDI 98a9b50c-99ed-4b61-96e7-1324eabb6406 36 fields · synced May 30, 2026