Identity
- Trade Name
- SZcaremed EUDAMED
- Device Name
- SpO2 Sensor EUDAMED
- Model / Reference
- C410F-21X EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06931973429854 EUDAMED
- Basic UDI-DI
- B-06931973429854 EUDAMED
- EMDN Code
- C900301 PULSE OXIMETER SENSORS EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- France EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
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
SZcaremed by Shenzhen Caremed Medical Technology 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-06931973429854 | Class IIb | Active |
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Manufacturer
- Manufacturer
- Shenzhen Caremed Medical Technology Co., Ltd.
- EUDAMED SRN
- CN-MF-000010579
- Authorised Representative
- SUNGO Europe B.V. NL-AR-000000247
Sources (1)
- EUDAMED db9bd402-29a1-4b47-94cc-a20104892200 61 fields · synced Jun 18, 2026