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OneTouch Delica Plus Ostrza
EUDAMEDClass IIa (EU MDR)
Ref 024-018Model 114301-592
Identity
- Trade Name
- OneTouch Delica Plus Ostrza EUDAMED
- Device Name
- OneTouch Delica Plus Lancet EUDAMED
- Model / Reference
- 114301-592 EUDAMED024-018 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04580505780110 EUDAMED
- Basic UDI-DI
- 458050578OTDPLANCETMX EUDAMED
- Unit of Use DI
- 84580505780116 EUDAMED
- EMDN Code
- V010402 LANCETS WITHOUT SAFETY SYSTEMS, SINGLE-USE EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Poland 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 Ostrza by Asahi Polyslider Company, Limited — Class IIa — MDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| 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 (1)
- EUDAMED 045d3aa6-8948-41ab-b6cc-59eaa6735e1f 61 fields · synced Jul 12, 2026