Identity
- Trade Name
- CO2 Incubator EUDAMED
- Device Name
- Heating Incubator EUDAMED
- Model / Reference
- ICB-CO2-30W EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06975488440867 EUDAMED
- Basic UDI-DI
- 697548844ICB22N8 EUDAMED
- EMDN Code
- W02039002 CARBON DIOXIDE INCUBATORS EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Spain 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
Category: Automated laboratory incubator
CO2 Incubator by Infitek Co., Ltd. — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
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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 | 697548844ICB22N8 | Class I | Active |
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Manufacturer
- Manufacturer
- Infitek Co., Ltd.
- EUDAMED SRN
- CN-MF-000040107
- Authorised Representative
- RIOMAVIX SOCIEDAD LIMITADA ES-AR-000001202
Sources (1)
- EUDAMED d77fc961-af97-4abb-b479-7f771c1ccfba 61 fields · synced Jun 18, 2026