Identity
- Device Name
- Reusable Surgical Instruments EUDAMED
- Model / Reference
- RJ8138015 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06941832550247 EUDAMED
- Basic UDI-DI
- 69418325P2021036269F EUDAMED
- Direct Marketing DI
- 06941832550247 EUDAMED
- EMDN Code
- L26 SURGICAL SCREWDRIVERS, REUSABLE 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
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Category: Surgical screwdriver, reusable
Reusable Surgical Instruments by Hangzhou Rejoin Mastin Medical Device Co., Ltd. — Class I — 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 | 69418325P2021036269F | Class I | Active |
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Manufacturer
- Manufacturer
- Hangzhou Rejoin Mastin Medical Device Co.,Ltd.
- EUDAMED SRN
- CN-MF-000006572
- Authorised Representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Sources (1)
- EUDAMED 975bf245-98c5-4285-95fe-229d8385bb60 61 fields · synced Jun 19, 2026