Identity
- Trade Name
- Heuer EUDAMED
- Device Name
- IV Infusion/Administration Set - Superior EUDAMED
- Model / Reference
- 10-320 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 89044078002754 EUDAMED
- Basic UDI-DI
- 890440781032068 EUDAMED
- EMDN Code
- A03040199 INFUSION KITS (WITH OR W/O PUMP), SINGLE-USE - OTHER EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Bulgaria EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
Yes
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
Heuer by G.S.T. Corporation Limited — Class IIa — CE/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 | 890440781032068 | Class IIa | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- G.S.T. Corporation Limited
- EUDAMED SRN
- IN-MF-000040767
- Authorised Representative
- Obelis s.a. BE-AR-000000106
Sources (1)
- EUDAMED cec1cd3d-ec9c-4ef2-9d71-4f0dc7a0508b 61 fields · synced Oct 7, 2026