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ToxiSeal Vial Adaptor with External Balloon and Valve (DMA Compatible) 20 mm vi…
EUDAMEDClass I (EU MDR)
Ref 420315
Identity
- Trade Name
- ToxiSeal Vial Adaptor with External Balloon and Valve (DMA Compatible) 20 mm vial EUDAMED
- Device Name
- CSTD and Administration Devices EUDAMED
- Model / Reference
- 420315 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 58859299130311 EUDAMED
- Basic UDI-DI
- 88592991B014UD EUDAMED
- Unit of Use DI
- 48859299130314 EUDAMED
- EMDN Code
- A0704 SYSTEMS FOR RECONSTITUTION AND ADMINISTRATION OF PHARMACEUTICALS EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Ireland EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
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
ToxiSeal Vial Adaptor with External Balloon and Valve (DMA Compatible) 20 mm vi… by Epic International (Thailand) Co., Ltd. — Class I — MDR — listed in EUDAMED
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 88592991B014UD | Class I | Active |
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Manufacturer
- Manufacturer
- Epic International (Thailand) Co., Ltd.
- EUDAMED SRN
- TH-MF-000012102
- Authorised Representative
- Medical Technology Promedt Consulting GmbH DE-AR-000000085
Sources (1)
- EUDAMED e948bb48-b6ec-4a69-b6d0-0d66fafbcabb 61 fields · synced Sep 17, 2026