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OneTouch Delica Plus Lancet
EUDAMEDClass IIa (EU MDR)
Ref 024-016Model 114301-592
Identity
- Trade Name
- OneTouch Delica Plus Lancet EUDAMEDOneTouch Delica Plus Lanzetten EUDAMED
- Device Name
- OTDP Lancet 100 EUR EUDAMEDOneTouch Delica Plus Lancet EUDAMED
- Model / Reference
- 114301-592 EUDAMED024-016 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04580505780097 EUDAMED
- Basic UDI-DI
- B-04580505780097 EUDAMED458050578OTDPLANCETMX EUDAMED
- Unit of Use DI
- 84580505780093 EUDAMED
- EMDN Code
- V010402 LANCETS WITHOUT SAFETY SYSTEMS, SINGLE-USE EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Germany 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-04580505780097 | Class IIa | Active |
| EUDAMED | European Union | CE/MDD | B-04580505780097 | 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 7b9d999f-0713-4482-8e3b-4c9c635435c3 61 fields · synced Jul 25, 2026
- EUDAMED ad656e41-ee13-4e29-a86b-6d26c977361b 61 fields · synced Jul 25, 2026