← Back to catalogue
OneTouch
EUDAMEDClass IIa (EU MDR)
Ref 024-280Ref 024-332Ref 01-0130 Soft 30GRef 024-337Ref 02-2201 LDE4Ref 024-279 Soft/UltraSoft 2 30G
Identity
- Trade Name
- OneTouch EUDAMEDONETOUCH UltraSoft EUDAMED
- Device Name
- Disposable Blood Lancets EUDAMEDLancing Device EUDAMED
- Model / Reference
- 024-280 EUDAMED024-332 EUDAMED01-0130 Soft 30G EUDAMED024-337 EUDAMED02-2201 LDE4 EUDAMED024-279 Soft/UltraSoft 2 30G EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06945630117107 EUDAMED06945630116742 EUDAMED06945630117121 EUDAMED06945630116735 EUDAMED06945630116773 EUDAMED06945630116728 EUDAMED
- Basic UDI-DI
- 6945630101DUX EUDAMED6945630102BB EUDAMED6945630101B9 EUDAMED
- EMDN Code
- V010402 LANCETS WITHOUT SAFETY SYSTEMS, SINGLE-USE EUDAMED
Classification
- Device Class
- Class IIa EUDAMEDClass I EUDAMED
- Market of Registration
- Spain EUDAMEDAustria EUDAMEDItaly EUDAMEDBelgium EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMEDEUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMEDEUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
CMR Substance
No
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 by Sterilance Medical (Suzhou) Inc. — 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 | 6945630101DUX | Class IIa | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Sterilance Medical (Suzhou) Inc.
- EUDAMED SRN
- CN-MF-000002860
- Authorised Representative
- Emergo Europe B.V. NL-AR-000000116
Sources (6)
- EUDAMED c5306e5d-5034-4d83-b1a9-7779bf6a2c55 61 fields · synced Jul 23, 2026
- EUDAMED 479233a5-e0e1-4056-b2c4-c09513573575 61 fields · synced May 16, 2026
- EUDAMED ef1a2b03-4e92-4733-b394-88c0f2cbd4ad 61 fields · synced May 17, 2026
- EUDAMED 237835e1-432d-4849-97ad-96836bc19d55 61 fields · synced May 17, 2026
- EUDAMED 0adbe513-6684-4c32-96b9-ed142328ec81 61 fields · synced May 17, 2026
- EUDAMED e3b32591-97ff-4f96-8df5-cc27cc9797b4 61 fields · synced May 18, 2026