Identity
- Trade Name
- High Pressure Syringe EUDAMEDAntmed FDA UDI
- Generic Name
- Contrast medium injection system syringe FDA UDI
- Device Name
- High Pressure Syringe EUDAMEDAngiographic Syringe FDA UDI
- Model / Reference
- 400101 EUDAMEDFDA UDI
- Description
- Angiographic Syringe FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06945764401516 EUDAMEDFDA UDI
- Basic UDI-DI
- 69457644HPS0000001HG EUDAMED
- FDA Product Code
- DXT FDA UDI
- EMDN Code
- A020102010102 INFUSION AND IRRIGATION SYRINGES, 2-PIECE LUER CONE, 2-PIECE WITHOUT NEEDLE, SINGLE-USE 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
- Germany 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
Yes
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
High Pressure Syringe by ShenZhen Antmed Co., Ltd — Class IIa — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
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 | 69457644HPS0000001HG | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- Shenzhen Antmed Co., Ltd
- EUDAMED SRN
- CN-MF-000029659
- Authorised Representative
- MedNet EC-REP C IIb GmbH DE-AR-000011194
Sources (2)
- EUDAMED ef1205ad-e5d5-48e4-92ae-c3bec207a7c7 61 fields · synced Aug 4, 2026
- FDA UDI d097cd49-7b4d-4fb1-ba03-f7d10e42460b 34 fields · synced May 30, 2026