Identity
- Trade Name
- SPENGLER EUDAMED
- Device Name
- Pulse oximeter EUDAMED
- Model / Reference
- DB12 EUDAMED5012731509 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04713072980953 EUDAMED
- Basic UDI-DI
- B-04713072980953 EUDAMED
- EMDN Code
- Z1203020408 PULSE OXIMETERS EUDAMED
Classification
- Device Class
- Class IIa 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
Spengler by Delbio Inc. — Class IIa — 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-04713072980953 | Class IIa | Active |
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Manufacturer
- Manufacturer
- Delbio Inc.
- EUDAMED SRN
- TW-MF-000003400
- Authorised Representative
- Delta Electronics (Netherlands) B.V. NL-AR-000001692
Sources (1)
- EUDAMED 783893da-e91a-40ca-9579-017c7812f53e 61 fields · synced Jun 17, 2026