Identity
- Trade Name
- ProSeal Universal Non-Vented Bag Spike EUDAMED
- Device Name
- CSTD and Administration Devices EUDAMED
- Model / Reference
- 423940 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 18859299133949 EUDAMED
- Basic UDI-DI
- 88592991B014UD EUDAMED
- EMDN Code
- A070103 INFUSION TUBING ADAPTERS AND CONNECTORS 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 Universal Non-Vented Bag Spike 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 1fb6dd7b-1b68-4ee2-8ca1-6fa42d6f0aed 61 fields · synced Oct 6, 2026