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OneTouch Delica Plus Lancet
EUDAMEDClass IIa (EU MDR)
Ref 023-999Model 114301-592
Identity
- Trade Name
- OneTouch Delica Plus Lancet EUDAMED
- Device Name
- OTDP Lancet 25 GB EUDAMED
- Model / Reference
- 114301-592 EUDAMED023-999 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04580505780028 EUDAMED
- Basic UDI-DI
- B-04580505780028 EUDAMED
- EMDN Code
- V010402 LANCETS WITHOUT SAFETY SYSTEMS, SINGLE-USE EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Northern Ireland EUDAMED
Clinical & Handling
Sterile
Yes
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
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
OneTouch Delica Plus Lancet by Asahi Polyslider Company, Limited — 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-04580505780028 | Class IIa | Active |
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Manufacturer
- Manufacturer
- Asahi Polyslider Company, Limited
- EUDAMED SRN
- JP-MF-000009245
- Authorised Representative
- LifeScan Deutschland GmbH DE-AR-000005105
Sources (1)
- EUDAMED bbc72afc-92ec-4377-9923-c474277fd521 61 fields · synced May 23, 2026