Identity
- Trade Name
- Finger Oximeter EUDAMED
- Device Name
- Finger Oximeter EUDAMED
- Model / Reference
- H10 EUDAMEDH10A EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06944413817111 EUDAMED06944413817524 EUDAMED
- Basic UDI-DI
- 69444138H10XF EUDAMED
- EMDN Code
- Z1203020408 PULSE OXIMETERS EUDAMED
Classification
- Device Class
- Class IIa 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
Finger Oximeter by Edan Instruments, Inc. — Class IIa — 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 | 69444138H10XF | Class IIa | Active |
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Manufacturer
- Manufacturer
- Edan Instruments, Inc.
- EUDAMED SRN
- CN-MF-000009957
- Authorised Representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Sources (2)
- EUDAMED 3ea2f0a6-4420-4a07-b8b4-efccd1e4cccb 61 fields · synced Sep 18, 2026
- EUDAMED 0abcbe78-89ca-46ae-8219-4511e84bd6f7 61 fields · synced Jul 16, 2026