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High Pressure Syringe
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref 100104TRef 300201Ref 100111Ref 410202Ref 400103BRef 400106Ref 300303Ref 400301ARef 100105Ref 100108Ref 400307Ref 500102Ref 100104BRef 100104Ref 400301BRef 100106Ref 300107Ref 400103ARef 200104ARef 400105Ref 500201Ref 100109Ref 400303Ref 100107Ref 200204Ref 420100
Identity
- Trade Name
- High Pressure Syringe EUDAMEDAntmed FDA UDI
- Generic Name
- Contrast medium injection system syringe FDA UDI
- Device Name
- High Pressure Syringe EUDAMED
- Model / Reference
- 100104T EUDAMED300201 EUDAMED100111 EUDAMED410202 EUDAMED400103B EUDAMED400106 EUDAMED300303 EUDAMED400301A EUDAMED100105 EUDAMED100108 EUDAMED400307 EUDAMED500102 EUDAMED100104B EUDAMED100104 EUDAMED400301B EUDAMED100106 EUDAMED300107 EUDAMED400103A EUDAMED200104A EUDAMED400105 EUDAMED500201 EUDAMED100109 EUDAMED400303 EUDAMED100107 EUDAMED200204 EUDAMEDFDA UDI420100 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06945764427189 EUDAMED06945764401059 EUDAMED06945764401776 EUDAMED06945764427455 EUDAMED06945764401745 EUDAMED06945764401813 EUDAMED06945764400755 EUDAMED06945764401714 EUDAMED06945764400052 EUDAMED06945764400205 EUDAMED06945764401875 EUDAMED06945764401578 EUDAMED06945764400182 EUDAMED06945764400045 EUDAMED06945764401721 EUDAMED06945764400069 EUDAMED06945764401103 EUDAMED06945764401738 EUDAMED06945764400687 EUDAMED06945764401707 EUDAMED06945764430073 EUDAMED06945764400151 EUDAMED06945764401752 EUDAMED06945764401783 EUDAMED06945764400595 EUDAMEDFDA UDI06945764400779 EUDAMED
- 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
- Netherlands EUDAMEDGermany 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 (27)
- EUDAMED 930dfbb2-6bee-4ec7-a9ce-5eb0b2bd7dae 61 fields · synced Oct 6, 2026
- EUDAMED a91e6f9c-7a2a-48f2-be5d-175a9fb5c5d6 61 fields · synced May 11, 2026
- EUDAMED ca541b95-d6c8-4e2d-bf19-f8088c436ec8 61 fields · synced May 16, 2026
- EUDAMED fb525307-ba67-4185-a607-fbc177e09242 61 fields · synced May 16, 2026
- EUDAMED 57beea45-b7a2-4902-80d9-0e4573291752 61 fields · synced May 16, 2026
- EUDAMED d0a6f80e-a961-4fcd-994d-af8370aa1a7b 61 fields · synced May 16, 2026
- EUDAMED c54d27cf-d604-4e20-ba3c-c8c034dcb984 61 fields · synced May 16, 2026
- EUDAMED e4c801e6-c702-4ef0-8e27-0a182e72f5e3 61 fields · synced May 17, 2026
- EUDAMED 5a53269b-027c-4489-8591-b3d024d595f1 61 fields · synced May 17, 2026
- EUDAMED 027f662b-42d6-4ccc-999d-5731f8a2f48d 61 fields · synced May 17, 2026
- EUDAMED 03fc1b4b-eb71-4e6b-9200-ad7ae9fcaaf7 61 fields · synced May 17, 2026
- EUDAMED 6586e609-d0f3-4f0e-8c59-44ae32d73db7 61 fields · synced May 17, 2026
- EUDAMED 59e888a1-f0c6-4bd8-9fbe-e49ac516a7ac 61 fields · synced May 18, 2026
- EUDAMED 86071efb-265d-4c9d-afca-a7cb3c404b38 61 fields · synced May 18, 2026
- EUDAMED b3a97e98-9a0f-4b11-8043-3188dde01953 61 fields · synced May 18, 2026
- EUDAMED 1b05835c-90d5-4c5b-9e64-8401b5ae550d 61 fields · synced May 18, 2026
- EUDAMED 4bf9858f-4b93-4b29-b9dc-62672a32eb27 61 fields · synced May 18, 2026
- EUDAMED b7664a4e-7d8f-4339-82b5-657e46dd44be 61 fields · synced May 18, 2026
- EUDAMED 98ecadb4-2107-4df9-bd8f-dfa0289ff024 61 fields · synced May 18, 2026
- EUDAMED 706d396f-5e75-41a8-8b71-20ea5e9dc19a 61 fields · synced May 18, 2026
- EUDAMED 45085835-072a-43f5-b098-39c241b6db82 61 fields · synced May 19, 2026
- EUDAMED 686a45cb-d081-4d28-983d-611dbd6fed68 61 fields · synced May 19, 2026
- EUDAMED e721ce96-5926-40b7-a00c-c88832ce09c0 61 fields · synced May 19, 2026
- EUDAMED 57255da0-b952-47eb-8871-9f43f0e48a27 61 fields · synced May 19, 2026
- EUDAMED 269317a4-d133-4189-9c69-d6ceb714eb68 61 fields · synced May 19, 2026
- FDA UDI 527668b1-557c-478f-98fc-1c100226f2a5 33 fields · synced May 29, 2026
- EUDAMED 5881ee77-fc4a-4e13-8153-c098131e44fd 61 fields · synced Jul 8, 2026