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eprodics
EUDAMEDClass IIa (EU MDR)
Ref 05-193015 Impress Pro 30G 1.5mmRef 01-1928 SoftSense 28GRef 01-0128 Soft 28GRef 05-192124 Impress Pro 21G 2.4mm
Identity
- Trade Name
- eprodics EUDAMED
- Device Name
- Disposable Safety Lancets EUDAMEDDisposable Blood Lancets EUDAMED
- Model / Reference
- 05-193015 Impress Pro 30G 1.5mm EUDAMED01-1928 SoftSense 28G EUDAMED01-0128 Soft 28G EUDAMED05-192124 Impress Pro 21G 2.4mm EUDAMED
Identifiers
- Primary DI / UDI-DI
- 16945630134385 EUDAMED16945630134392 EUDAMED16945630135405 EUDAMED16945630134378 EUDAMED
- Basic UDI-DI
- 6945630105BH EUDAMED6945630101B9 EUDAMED
- Unit of Use DI
- 06945630134388 EUDAMED06945630134395 EUDAMED06945630135408 EUDAMED06945630134371 EUDAMED
- EMDN Code
- V010401 LANCETS WITH SAFETY SYSTEMS, SINGLE-USE EUDAMEDV010402 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
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
Category: Blood lancet, single-use
eprodics by Sterilance Medical (Suzhou) Inc. — Class IIa — MDR — 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
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 6945630105BH | Class IIa | Active |
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Manufacturer
- Manufacturer
- Sterilance Medical (Suzhou) Inc.
- EUDAMED SRN
- CN-MF-000002860
- Authorised Representative
- Emergo Europe B.V. NL-AR-000000116
Sources (4)
- EUDAMED 74cdbb0e-b54d-490a-90b0-90e61b25e5b3 61 fields · synced Jul 23, 2026
- EUDAMED 484faa57-77ca-4b8a-94ba-0460e01cecbc 61 fields · synced May 17, 2026
- EUDAMED 93056f7b-d13f-4376-b157-4a8da0893432 61 fields · synced May 17, 2026
- EUDAMED 4f1b41cc-9113-4d63-a7a6-b83e9d7b9e33 61 fields · synced May 18, 2026