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Sterile High-pressure Angiographic Syringes for Single-use Accessory
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref 801106B
Identity
- Trade Name
- Sterile High-pressure Angiographic Syringes for Single-use Accessory EUDAMEDLF FDA UDI
- Generic Name
- Radiographic procedure tubing FDA UDI
- Device Name
- Sterile High-pressure Angiographic Syringes for Single-use Accessory EUDAMED60"(1500mm) Y Tubing with Single Check Valve FDA UDI
- Model / Reference
- 801106B EUDAMED400102-3 FDA UDI
- Description
- 60"(1500mm) Y Tubing with Single Check Valve FDA UDI
Identifiers
- Catalog Number
- 801106B FDA UDI
- Primary DI / UDI-DI
- 06938327906214 EUDAMEDFDA UDI
- Basic UDI-DI
- B-06938327906214 EUDAMED
- 510(k) Number
- K182289 FDA UDI
- FDA Product Code
- DXT FDA UDI
- EMDN Code
- A02010401 SYRINGES FOR CONTRAST MEDIA INJECTOR, SINGLE-USE EUDAMED
- GMDN Term
- Radiographic procedure tubing 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 Accessory by Shenzhen Boon Medical Supply Co., Ltd. — Class IIa — MDD, FDA UDI — listed in EUDAMED…
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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-06938327906214 | 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 68c230c3-3070-42dc-854b-6cf3906d7761 61 fields · synced Jun 18, 2026
- FDA UDI cf4dfc9d-d12a-42dd-bb57-05fae455a869 37 fields · synced May 30, 2026