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ProSeal Vented Vial Adaptor for 20 - 28 mm Vial
EUDAMEDClass I (EU MDR)
Ref 420680ST
Identity
- Trade Name
- ProSeal Vented Vial Adaptor for 20 - 28 mm Vial EUDAMED
- Device Name
- CSTD and Administration Devices EUDAMED
- Model / Reference
- 420680ST EUDAMED
Identifiers
- Primary DI / UDI-DI
- 18859299123247 EUDAMED
- Basic UDI-DI
- 88592991B014UD EUDAMED
- EMDN Code
- A0704 SYSTEMS FOR RECONSTITUTION AND ADMINISTRATION OF PHARMACEUTICALS EUDAMED
Classification
- Device Class
- Class I 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
ProSeal Vented Vial Adaptor for 20 - 28 mm Vial by Epic International (Thailand) Co., Ltd. — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
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 b75e9b21-fc9f-4df4-867a-17dee34fc446 61 fields · synced Oct 6, 2026