Identity
- Trade Name
- Disposable Syringe (Kit) EUDAMED
- Device Name
- Disposable Syringe for Power Injector EUDAMED
- Model / Reference
- TM0539O EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04719879052046 EUDAMED
- Basic UDI-DI
- B-04719879052046 EUDAMED
- EMDN Code
- A02010401 SYRINGES FOR CONTRAST MEDIA INJECTOR, SINGLE-USE EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
Yes
EUDAMED
Measuring Function
Yes
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Category: Angiography kit
Disposable Syringe (Kit) by Pacific Hospital Supply Co., Ltd. — Class IIa — MDD — listed in EUDAMED — regulatory data on deviCERTS
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Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-04719879052046 | Class IIa | Active |
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Manufacturer
- Manufacturer
- Pacific Hospital Supply Co., Ltd.
- EUDAMED SRN
- TW-MF-000007247
- Authorised Representative
- mdi Europa GmbH DE-AR-000006218
Sources (1)
- EUDAMED b23ebc8e-d41f-4869-aecb-3cfc15d9bf39 61 fields · synced Jun 19, 2026