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Aposán
EUDAMEDClass IIa (EU MDR)
Ref 5012733410 & 5012733510Model DB12
by Delbio Inc.
Identity
- Trade Name
- Aposán EUDAMED
- Device Name
- Fingertip Pulse Oximeter EUDAMED
- Model / Reference
- DB12 EUDAMED5012733410 & 5012733510 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04713072980939 EUDAMED
- Basic UDI-DI
- B-04713072980939 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
Aposán 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-04713072980939 | 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 94caaa4b-b3b7-4ce1-9995-663c90cc4cff 61 fields · synced Jun 20, 2026