Identity
- Device Name
- Reusable oral syringe EUDAMED
- Model / Reference
- OSR101(RE) EUDAMED
Identifiers
- Primary DI / UDI-DI
- 16930197883227 EUDAMED
- Basic UDI-DI
- 6930197820261ns75d01RG EUDAMED
- EMDN Code
- A020299 REUSABLE SYRINGES - OTHER EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
Yes
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
Yes
EUDAMED
Measuring Function
Yes
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Reusable oral syringe by Shanghai Kindly Enterprise Development Group Co., Ltd. — Class I — 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 | 6930197820261ns75d01RG | Class I | Active |
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Manufacturer
- EUDAMED SRN
- CN-MF-000005652
- Authorised Representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Sources (1)
- EUDAMED e061bfd8-48ab-4d72-9441-8677c0d29364 61 fields · synced Jul 8, 2026