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SpO2 sensor
EUDAMEDClass IIb (EU MDR)
Ref SRD-A12/15-100-0058Model SRD-A11/15-100-0013Ref SRA-A22/15-100-0359Ref SRA-N15/15-100-0353Ref SRA-P12/15-100-0323Ref SRA-A11/15-100-0320Ref SRA-N13/15-100-0324Ref SRA-A12/15-100-0321Ref SRD-A31/15-100-0333Ref SRD-A22/15-100-0338Ref SRD-P11/15-100-0014
Identity
- Trade Name
- SpO2 sensor EUDAMED
- Device Name
- SpO2 sensor EUDAMED
- Model / Reference
- SRD-A11/15-100-0013 EUDAMEDSRD-A12/15-100-0058 EUDAMEDSRA-A22/15-100-0359 EUDAMEDSRA-N15/15-100-0353 EUDAMEDSRA-P12/15-100-0323 EUDAMEDSRA-A11/15-100-0320 EUDAMEDSRA-N13/15-100-0324 EUDAMEDSRA-A12/15-100-0321 EUDAMEDSRD-A31/15-100-0333 EUDAMEDSRD-A22/15-100-0338 EUDAMEDSRD-P11/15-100-0014 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06932562300639 EUDAMED06932562300615 EUDAMED06932562300769 EUDAMED06932562300684 EUDAMED06932562300677 EUDAMED06932562300622 EUDAMED06932562300707 EUDAMED06932562300646 EUDAMED06932562300738 EUDAMED06932562300721 EUDAMED06932562300653 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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- LiDCO — LIDCO LIMITED · Class II
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 (11)
- EUDAMED 18873b13-5a9e-4b35-b6e3-459b30c5853e 61 fields · synced Jul 20, 2026
- EUDAMED 3fcf85d1-0bd6-4c30-b6d7-b102e0cecf32 61 fields · synced May 16, 2026
- EUDAMED 90631d69-7b93-4364-9354-7c2de2b1a676 61 fields · synced May 16, 2026
- EUDAMED ccd4a477-4b27-441b-85ac-ec33bfe431a7 61 fields · synced May 17, 2026
- EUDAMED 84973623-f325-4303-8738-32126a52f123 61 fields · synced May 17, 2026
- EUDAMED 19e4026a-2664-4939-b893-3e33e2aa8034 61 fields · synced May 17, 2026
- EUDAMED aec67f14-1cd2-4746-ad5e-91ba720275a4 61 fields · synced May 17, 2026
- EUDAMED e0548246-bf1b-49e4-af83-5c6921136fde 61 fields · synced May 17, 2026
- EUDAMED 1f3bb38a-cc3a-480c-a6d4-e347a3bd93d4 61 fields · synced May 18, 2026
- EUDAMED a0d7ac6a-322f-4206-bda4-95499908f5d0 61 fields · synced May 18, 2026
- EUDAMED f070715f-4a34-4af9-9fe0-a9e9444d4a0a 61 fields · synced May 18, 2026