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Sinmed
EUDAMEDClass IIa (EU MDR)
Ref SHU-1915CHYModel Type A;Type B;Type D;Type E;
Identity
- Trade Name
- SINMED EUDAMED
- Device Name
- Safety Huber Needles EUDAMED
- Model / Reference
- Type A;Type B;Type D;Type E; EUDAMEDSHU-1915CHY EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06978111920101 EUDAMED
- Basic UDI-DI
- 697122740SHUR9 EUDAMED
- Unit of Use DI
- 86978111920107 EUDAMED
- EMDN Code
- A01010301 NEEDLES AND KITS FOR IMPLANTABLE SYSTEMS (PORT), WITH SAFETY SYSTEMS EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Poland 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
Sinmed 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 | 697122740SHUR9 | 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 (1)
- EUDAMED 319bdaf3-8252-4375-80bf-74a72c7c129b 61 fields · synced Jun 18, 2026