← Back to catalogue
SpO2 Sensor
EUDAMEDClass IIb (EU MDR)
Ref HS-SN-3Ref HS-SN-1Ref HS-SI-2Ref HS-SN-2Ref HS-SI-1
Identity
- Trade Name
- SpO2 Sensor EUDAMED
- Device Name
- SpO2 Sensor EUDAMED
- Model / Reference
- HS-SN-3 EUDAMEDHS-SN-1 EUDAMEDHS-SI-2 EUDAMEDHS-SN-2 EUDAMEDHS-SI-1 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06944375391766 EUDAMED06944375391742 EUDAMED06944375391728 EUDAMED06944375391759 EUDAMED06944375391711 EUDAMED
- Basic UDI-DI
- B-06944375391766 EUDAMEDB-06944375391742 EUDAMEDB-06944375391728 EUDAMEDB-06944375391759 EUDAMEDB-06944375391711 EUDAMED
- EMDN Code
- C900301 PULSE OXIMETER SENSORS EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- Czechia EUDAMED
Clinical & Handling
Sterile
No
EUDAMEDEUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
Yes
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
SpO2 Sensor by Zhejiang Haisheng Medical Device Co., Ltd. — Class IIb — MDD — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-06944375391766 | Class IIb | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Zhejiang Haisheng Medical Device Co., Ltd.
- EUDAMED SRN
- CN-MF-000026345
- Authorised Representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Sources (5)
- EUDAMED 38c01147-85f0-4d6b-84f2-47efaa8d65d8 61 fields · synced Jul 18, 2026
- EUDAMED 104496c3-1211-4494-960e-2b65657217be 61 fields · synced May 17, 2026
- EUDAMED 265b621c-4f24-4b8c-afc4-39424f552f5e 61 fields · synced May 17, 2026
- EUDAMED 5e209d5e-d3e4-427e-b8d0-f868ff76d517 61 fields · synced May 18, 2026
- EUDAMED 1a7a378b-8d4a-49e3-8ad3-1f9c3f660b9c 61 fields · synced May 18, 2026