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SpO2 sensor
EUDAMEDClass IIb (EU MDR)
Ref SRD-N13/15-100-0015Model SRD-A11/15-100-0013
Identity
- Trade Name
- SpO2 sensor EUDAMED
- Device Name
- SpO2 sensor EUDAMED
- Model / Reference
- SRD-A11/15-100-0013 EUDAMEDSRD-N13/15-100-0015 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06932562300691 EUDAMED
- Basic UDI-DI
- 69325623500055D EUDAMED
- EMDN Code
- Z1203020285 MULTI-PARAMETER MONITORS - CONSUMABLES EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- Germany 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
Yes
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Category: General-purpose multi-parameter bedside monitor
SpO2 sensor by Guangdong Biolight Meditech Co., Ltd — Class IIb — MDR — listed in EUDAMED — regulatory data on deviCERTS
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Also classified as General-purpose multi-parameter bedside monitor.
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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 | 69325623500055D | Class IIb | Active |
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Manufacturer
- Manufacturer
- Guangdong Biolight Meditech Co., Ltd
- EUDAMED SRN
- CN-MF-000006333
- Authorised Representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Sources (1)
- EUDAMED 94046970-aee5-43c5-a9af-ffdbbdffa401 61 fields · synced Jun 19, 2026