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OneTouch Delica Safety
EUDAMEDClass IIa (EU MDR)
Ref 024-208Model 114401-606-PRef 024-224Model 114401-606Ref 024-209
Identity
- Trade Name
- OneTouch Delica Safety EUDAMED
- Device Name
- OTD Safety 30g EUR 200 EUDAMEDOTD Safety 30g EUR 100 EUDAMEDOneTouch Delica Safety EUDAMED
- Model / Reference
- 114401-606-P EUDAMED024-208 EUDAMED024-224 EUDAMED114401-606 EUDAMED024-209 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04580505780493 EUDAMED04580505780561 EUDAMED04580505780509 EUDAMED
- Basic UDI-DI
- B-04580505780493 EUDAMEDB-04580505780561 EUDAMED458050578OTDSHJ EUDAMED
- Unit of Use DI
- 84580505780567 EUDAMED84580505780505 EUDAMED
- EMDN Code
- V010401 LANCETS WITH SAFETY SYSTEMS, SINGLE-USE EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Austria EUDAMEDGermany 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
Category: Blood lancet, single-use
OneTouch Delica Safety by Asahi Polyslider Company, Limited — Class IIa — MDR, MDD — listed in EUDAMED — regulatory data on deviCERTS
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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-04580505780493 | Class IIa | Active |
| EUDAMED | European Union | CE/MDD | B-04580505780493 | 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 (5)
- EUDAMED 5dc9d028-22f3-4b11-835c-16139a8840b1 61 fields · synced Jul 28, 2026
- EUDAMED cb00e2ac-22d6-4831-a7ef-3502eaca6f49 61 fields · synced May 18, 2026
- EUDAMED fd6eb83d-7dc8-4199-bc13-f0337315f69a 61 fields · synced Jul 8, 2026
- EUDAMED 1c2daf56-60d3-4b7e-9b64-62ce702ddbaa 61 fields · synced Jul 24, 2026
- EUDAMED 564c30c8-5941-4556-8bd3-4b59879e83a6 61 fields · synced Jul 28, 2026