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Medical Imaging Solutions International
FDA UDIEUDAMEDClass II (US FDA UDI)
Ref 700101Model Large Spike
Identity
- Trade Name
- Sterile High-pressure Angiographic Syringes for Single-use EUDAMEDMedical Imaging Solutions International FDA UDI
- Generic Name
- Angiography kit FDA UDI
- Device Name
- Sterile High-pressure Angiographic Syringes for Single-use Accessory EUDAMED1-Large Spike FDA UDI
- Model / Reference
- 700101 EUDAMEDFDA UDILarge Spike EUDAMED
- Description
- 1-Large Spike FDA UDI
Identifiers
- Catalog Number
- 700101 FDA UDI
- Primary DI / UDI-DI
- 06938327901301 EUDAMEDFDA UDI
- Basic UDI-DI
- B-06938327901301 EUDAMED
- 510(k) Number
- K151960 FDA UDI
- 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
Medical Imaging Solutions International by Shenzhen Boon Medical Supply Co., Ltd. — Class II — MDD, FDA UDI — listed in FDA GUDID, EUDAMED
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Also classified as Angiography kit.
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Cleared under the same submission
K151960 also covers:
- LF — Shenzhen Boon Medical Supply Co., Ltd.
- LF — Shenzhen Boon Medical Supply Co., Ltd.
- LF — Shenzhen Boon Medical Supply Co., Ltd.
- LF — Shenzhen Boon Medical Supply Co., Ltd.
- Medical Imaging Solutions International — Shenzhen Boon Medical Supply Co., Ltd.
- Medical Imaging Solutions International — Shenzhen Boon Medical Supply Co., Ltd.
- Medical Imaging Solutions International — Shenzhen Boon Medical Supply Co., Ltd.
- Sinton Medical Products — Shenzhen Boon Medical Supply Co., Ltd.
- Steriatrics — Shenzhen Boon Medical Supply Co., Ltd.
- Steriatrics — Shenzhen Boon Medical Supply Co., Ltd.
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDD | — | Class II | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Shenzhen Boon Medical Supply Co., Ltd.
Sources (2)
- FDA UDI 2d05943b-b05b-46ec-8357-281ee4c470ff 37 fields · synced Jun 19, 2026
- EUDAMED 9b5c270b-0f33-4a08-9b16-bf8f3952a9dd 61 fields · synced Jun 19, 2026