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OneTouch Delica Plus Lancet
EUDAMEDClass IIa (EU MDR)
Ref 013-028Model 114301-592Ref 024-250Ref 024-012Ref 024-001Ref 024-013
Identity
- Trade Name
- OneTouch Delica Plus Lancet EUDAMEDOneTouch Delica Plus Lancets EUDAMEDOneTouch Delica Plus Lanzetten EUDAMEDOneTouch Delica Plus Lancettes EUDAMED
- Device Name
- OneTouch Delica Plus Lancet EUDAMEDOTDP Lancet 30 DE EUDAMEDOTDP Lancet 200 EUR EUDAMEDOTDP Lancet 200 GB EUDAMED
- Model / Reference
- 114301-592 EUDAMED013-028 EUDAMED024-250 EUDAMED024-012 EUDAMED024-001 EUDAMED024-013 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04580505780660 EUDAMED04580505780646 EUDAMED04580505780042 EUDAMED04580505780226 EUDAMED04580505780011 EUDAMED
- Basic UDI-DI
- 458050578OTDPLANCETMX EUDAMEDB-04580505780646 EUDAMEDB-04580505780042 EUDAMEDB-04580505780011 EUDAMED
- Unit of Use DI
- 84580505780666 EUDAMED84580505780222 EUDAMED84580505780642 EUDAMED
- EMDN Code
- V010402 LANCETS WITHOUT SAFETY SYSTEMS, SINGLE-USE EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Austria EUDAMEDGermany EUDAMEDCzechia EUDAMEDNorthern Ireland EUDAMEDFrance 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 — MDD, MDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDD
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | 458050578OTDPLANCETMX | Class IIa | Active |
| EUDAMED | European Union | CE/MDR | 458050578OTDPLANCETMX | Class IIa | Active |
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Manufacturer
- Manufacturer
- Asahi Polyslider Company, Limited
- EUDAMED SRN
- JP-MF-000009245
- Authorised Representative
- Emergo Europe B.V. NL-AR-000000116
Sources (7)
- EUDAMED f284b66c-6be7-492d-9014-fb402cb83f6b 61 fields · synced Jul 30, 2026
- EUDAMED 66ebc0eb-e713-4892-ba04-b34ee1397807 61 fields · synced May 18, 2026
- EUDAMED fdd982b2-1a7b-44a3-9bc9-2b5ebf751de0 61 fields · synced Jul 9, 2026
- EUDAMED 00998973-6224-4d75-a01c-47259b8e87d3 61 fields · synced Jul 9, 2026
- EUDAMED d0f0c658-1fd6-45b8-afec-7b78f1bd24ed 61 fields · synced Jul 10, 2026
- EUDAMED d1cece24-c643-4973-94db-4c3cc87d71ae 61 fields · synced Jul 28, 2026
- EUDAMED f5b0c5a6-faf5-4a7a-aa2f-e22c3b67cdd0 61 fields · synced Jul 30, 2026