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Láhev na moč s uzávěrem
EUDAMEDClass I (EU MDR)
Ref V204811Model Láhev na moč s uzávěrem
Identity
- Trade Name
- Láhev na moč s uzávěrem EUDAMED
- Device Name
- Láhev na moč s uzávěrem EUDAMED
- Model / Reference
- Láhev na moč s uzávěrem EUDAMEDV204811 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08593540353115 EUDAMED
- Basic UDI-DI
- 85935402LAHEVNAMOC98 EUDAMED
- EMDN Code
- V0812 FECES AND URINE COLLECTION AIDS (BED PANS AND PARROTS) EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Czechia EUDAMED
Clinical & Handling
Sterile
No
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
This Láhev na moč s uzávěrem medical device, also known as a GAMA GROUP a.s. insulin pump, is designed to provide precise and controlled dosing of insulin for patients with diabetes. Its sterile and disposable design ensures the highest level of patient safety. With its class I classification according to the CE mark, this device meets the highest standards of safety and efficacy.
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 | 85935402LAHEVNAMOC98 | Class I | Active |
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Manufacturer
- Manufacturer
- GAMA GROUP a.s.
- EUDAMED SRN
- CZ-MF-000011894
Sources (1)
- EUDAMED bfef46b8-7879-43fe-962e-e0253751b609 61 fields · synced Jul 6, 2026