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Disposable Syringe (Kit)
EUDAMEDClass IIa (EU MDR)
Ref TM0539APRef TM0539ALRef TM0539RRef TM0539TRef TM0539AHRef TM0539URef TM0544FRef TM0539NRef TM053900A
Identity
- Trade Name
- Disposable Syringe (Kit) EUDAMEDDisposable Syringe EUDAMED
- Device Name
- Disposable Syringe for Power Injector EUDAMED
- Model / Reference
- TM0539AP EUDAMEDTM0539AL EUDAMEDTM0539R EUDAMEDTM0539T EUDAMEDTM0539AH EUDAMEDTM0539U EUDAMEDTM0544F EUDAMEDTM0539N EUDAMEDTM053900A EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04719879053708 EUDAMED04719879057072 EUDAMED04719879052053 EUDAMED04719879052077 EUDAMED04719873433520 EUDAMED04719879052084 EUDAMED04719879052305 EUDAMED04719879052039 EUDAMED04719879057164 EUDAMED
- Basic UDI-DI
- B-04719879053708 EUDAMEDB-04719879057072 EUDAMEDB-04719879052053 EUDAMEDB-04719879052077 EUDAMEDB-04719873433520 EUDAMEDB-04719879052084 EUDAMEDB-04719879052305 EUDAMEDB-04719879052039 EUDAMEDB-04719879057164 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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Also classified as Angiography kit.
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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-04719879053708 | 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 (9)
- EUDAMED c54330c4-43b9-43a7-a348-6f86ff10bd0c 61 fields · synced Jul 21, 2026
- EUDAMED b78f8ba3-c1ee-487d-ba1d-86ae49698d9a 61 fields · synced May 17, 2026
- EUDAMED 53253a14-35c5-4b1f-806c-e49d17b80b84 61 fields · synced May 17, 2026
- EUDAMED d8976b68-a2d9-4cdd-9d37-d58fa9dfd785 61 fields · synced May 17, 2026
- EUDAMED d61dcb14-5372-4ce5-b4c4-47119cef6fb1 61 fields · synced May 17, 2026
- EUDAMED fe8450ad-ea76-4ec7-ad17-cbde7ae047d0 61 fields · synced May 18, 2026
- EUDAMED e73518e2-d301-4a31-97da-f3b239b92961 61 fields · synced May 18, 2026
- EUDAMED 5dd37987-218c-441b-8f80-4a4439b77033 61 fields · synced May 18, 2026
- EUDAMED 2b69001c-5278-47ad-b2ff-59674d5df36f 61 fields · synced May 19, 2026