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OneTouch Delica Plus Lancette
EUDAMEDClass IIa (EU MDR)
Ref 013-029Model 114301-592
Identity
- Trade Name
- OneTouch Delica Plus Lancette EUDAMED
- Device Name
- OneTouch Delica Plus Lancet EUDAMED
- Model / Reference
- 114301-592 EUDAMED013-029 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04580505780721 EUDAMED
- Basic UDI-DI
- 458050578OTDPLANCETMX EUDAMED
- Unit of Use DI
- 84580505780727 EUDAMED
- EMDN Code
- V010402 LANCETS WITHOUT SAFETY SYSTEMS, SINGLE-USE EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Spain 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 Lancette 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 74979860-2492-4644-9732-30c9cbe11019 61 fields · synced Jul 31, 2026