Identity
- Trade Name
- Infuzní souprava IS-127 P® 180 cm M EUDAMED
- Device Name
- Infuzní souprava pro přetlakovou infuzi EUDAMED
- Model / Reference
- V606128-M EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08593540513403 EUDAMED
- Basic UDI-DI
- 85935406TF03ISPRETLAKKM EUDAMED
- EMDN Code
- A03040199 INFUSION KITS (WITH OR W/O PUMP), SINGLE-USE - OTHER EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Czechia 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
Infuzní souprava IS-127 P® 180 cm M by GAMA GROUP a.s. — Class IIa — 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 | 85935406TF03ISPRETLAKKM | Class IIa | Active |
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Manufacturer
- Manufacturer
- GAMA GROUP a.s.
- EUDAMED SRN
- CZ-MF-000011894
Sources (1)
- EUDAMED f8047a4a-f32b-4992-8631-c1b6b06d5e7f 61 fields · synced Jul 17, 2026