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OneTouch Delica Plus Lancet
EUDAMEDClass IIa (EU MDR)
Ref 024-024Model 114301-592
Identity
- Trade Name
- OneTouch Delica Plus Lancet EUDAMEDOneTouch Delica Plus Lancettes EUDAMED
- Device Name
- OTDP Lancet 200 FR RMB EUDAMEDOneTouch Delica Plus Lancet EUDAMED
- Model / Reference
- 114301-592 EUDAMED024-024 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04580505780059 EUDAMED
- Basic UDI-DI
- B-04580505780059 EUDAMED458050578OTDPLANCETMX EUDAMED
- Unit of Use DI
- 84580505780055 EUDAMED
- EMDN Code
- V010402 LANCETS WITHOUT SAFETY SYSTEMS, SINGLE-USE EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- France EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
CMR Substance
Yes
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
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 — MDR, MDD — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | B-04580505780059 | Class IIa | Active |
| EUDAMED | European Union | CE/MDD | B-04580505780059 | 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 (2)
- EUDAMED f5af65b5-8614-4677-8c27-56f48d64e4eb 61 fields · synced Jul 9, 2026
- EUDAMED a3aac57d-abcc-488f-a5cc-edbb4cfcbac4 61 fields · synced Jun 18, 2026