Identity
- Trade Name
- 2-8℃ Refrigerator EUDAMED
- Device Name
- 2-8℃ Refrigerator EUDAMED
- Model / Reference
- PR5-60 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06975488440294 EUDAMED
- Basic UDI-DI
- 697548844PR522S2 EUDAMED
- Direct Marketing DI
- 06975488440294 EUDAMED
- EMDN Code
- W020702 CRYOGENICS / FROZEN 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
2-8℃ Refrigerator by Infitek Co., Ltd. — 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 | 697548844PR522S2 | 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 41736591-920d-4b78-9717-4f81c13486f0 61 fields · synced Jun 18, 2026