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Sinodraw
EUDAMEDClass IIa (EU MDR)
Ref SL-30-18MModel Type A, Type B, Type C, Type T, Type MRef SL-28-18M
Identity
- Trade Name
- Sinodraw EUDAMED
- Device Name
- Safety Blood Lancets EUDAMED
- Model / Reference
- Type A, Type B, Type C, Type T, Type M EUDAMEDSL-30-18M EUDAMEDSL-28-18M EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06978111925748 EUDAMED06978111925847 EUDAMED06978111925830 EUDAMED
- Basic UDI-DI
- 697122740SLYU EUDAMED
- Unit of Use DI
- 86978111925744 EUDAMED86978111925843 EUDAMED86978111925836 EUDAMED
- EMDN Code
- V010401 LANCETS WITH SAFETY SYSTEMS, SINGLE-USE EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Sweden 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 Promisemed Hangzhou Meditech Co., Ltd. — 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 | 697122740SLYU | Class IIa | Active |
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Manufacturer
- Manufacturer
- Promisemed Hangzhou Meditech Co., Ltd.
- EUDAMED SRN
- CN-MF-000008465
- Authorised Representative
- Obelis s.a. BE-AR-000000106
Sources (3)
- EUDAMED bcb6693d-b512-4e0f-a62c-660ea2fae6c9 61 fields · synced Oct 6, 2026
- EUDAMED 102b2a25-880f-444f-b878-5f950761273a 61 fields · synced May 17, 2026
- EUDAMED 0a007175-696a-4b24-8541-45ec66b89e3d 61 fields · synced May 18, 2026