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Fingertip Pulse Oximeter
EUDAMEDClass IIa (EU MDR)
Ref DB110-206Model DB110
by Delbio Inc.
Identity
- Device Name
- Fingertip Pulse Oximeter EUDAMED
- Model / Reference
- DB110 EUDAMEDDB110-206 EUDAMED
Identifiers
- Primary DI / UDI-DI
- D-DB110-2063K EUDAMED
- Basic UDI-DI
- B-DB110-2063K EUDAMED
- EMDN Code
- Z1203020408 PULSE OXIMETERS EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Spain 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
Fingertip Pulse Oximeter 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-DB110-2063K | 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 c292be70-b612-4eb2-b196-542c8d066324 61 fields · synced Aug 1, 2026