← Back to catalogue
Sinodraw
EUDAMEDClass IIa (EU MDR)
Ref Soft 28GRef Press 28G 1.8mm Ref 01-0128 Soft 28GRef Press 21G 2.8mmRef 01-0128
Identity
- Trade Name
- Sinodraw EUDAMED
- Device Name
- Disposable Blood Lancets EUDAMEDDisposable Safety Lancets EUDAMED
- Model / Reference
- Soft 28G EUDAMEDPress 28G 1.8mm EUDAMED01-0128 Soft 28G EUDAMEDPress 21G 2.8mm EUDAMED01-0128 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 16945630140713 EUDAMED16945630120678 EUDAMED16945630132206 EUDAMED16945630133067 EUDAMED16945630132183 EUDAMED16945630141352 EUDAMED16945630124157 EUDAMED16945630120531 EUDAMED
- Basic UDI-DI
- 6945630101B9 EUDAMED6945630105BH EUDAMED
- Unit of Use DI
- 06945630140716 EUDAMED06945630120664 EUDAMED06945630132209 EUDAMED06945630133060 EUDAMED06945630132186 EUDAMED06945630141355 EUDAMED06945630124150 EUDAMED06945630120534 EUDAMED
- EMDN Code
- V010402 LANCETS WITHOUT SAFETY SYSTEMS, SINGLE-USE EUDAMEDV010401 LANCETS WITH SAFETY SYSTEMS, SINGLE-USE EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Italy EUDAMEDAustria 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
Sinodraw 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 | 6945630101B9 | 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 (8)
- EUDAMED 60e42eca-e287-4e25-88e0-ccea87651549 61 fields · synced Sep 30, 2026
- EUDAMED 611403f3-a8fa-407d-ac02-648256b12d2f 61 fields · synced May 17, 2026
- EUDAMED 0b743f87-db41-413b-8122-b26c33004546 61 fields · synced May 17, 2026
- EUDAMED dcc70485-4b07-4e97-85bd-c6d00e0539a8 61 fields · synced May 17, 2026
- EUDAMED 5a82f0ab-39cc-4089-85f2-345762843750 61 fields · synced May 17, 2026
- EUDAMED 9a96415e-9a9a-44e6-b7d7-de840e328eba 61 fields · synced May 18, 2026
- EUDAMED 80ce9c12-efd3-4fb2-8bc3-4ece1c00e716 61 fields · synced May 19, 2026
- EUDAMED eb31e45d-ddad-4ec8-b65a-888ce53ff51a 61 fields · synced May 19, 2026