Identity
- Trade Name
- Infúzna súprava IS-103 EUDAMEDInfúzna súprava IS-103 – bal. 4x50 ks EUDAMED
- Device Name
- Infúzní souprava pro gravitační infúze EUDAMED
- Model / Reference
- V606103-ND EUDAMEDV606103-01ND EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08593540507785 EUDAMED08593540507808 EUDAMED
- Basic UDI-DI
- 85935406TF02ISGRAVITACHE EUDAMED
- EMDN Code
- A03040199 INFUSION KITS (WITH OR W/O PUMP), SINGLE-USE - OTHER EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Slovakia EUDAMEDCzechia 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
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Infúzna súprava IS-103 by GAMA GROUP a.s. — 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 | 85935406TF02ISGRAVITACHE | Class I | Active |
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Manufacturer
- Manufacturer
- GAMA GROUP a.s.
- EUDAMED SRN
- CZ-MF-000011894
Sources (2)
- EUDAMED 1ec1c5a0-d0be-4791-942f-0dd938d5001c 61 fields · synced Jul 14, 2026
- EUDAMED 689603db-6869-4a8a-b708-3780223b1095 61 fields · synced May 17, 2026