Identity
- Trade Name
- Kabel SPO2 EUDAMED
- Device Name
- Kabel SPO2 EUDAMED
- Model / Reference
- PK-GDB9x-21/L-300 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05903002208380 EUDAMED
- Basic UDI-DI
- 5903002221055E EUDAMED
- EMDN Code
- Z1203020680 VITAL SIGNS TELEMETRY INSTRUMENTS - HARDWARE ACCESSORIES EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Poland 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
Kabel SPO2 by SORIMEX sp. z o.o. — 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 | 5903002221055E | Class I | Active |
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Manufacturer
- Manufacturer
- SORIMEX sp. z o.o.
- EUDAMED SRN
- PL-MF-000020958
Sources (1)
- EUDAMED 02bb6f04-95cf-48bf-8014-890191c4cfe4 61 fields · synced Jun 18, 2026