Identity
- Device Name
- Reusable Surgical Instruments EUDAMED
- Model / Reference
- 801311300 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06970399633049 EUDAMED
- Basic UDI-DI
- 69418325P2021036249B EUDAMED
- Direct Marketing DI
- 06970399633049 EUDAMED
- EMDN Code
- L0927 ORTHOPAEDIC SURGERY MANUAL PERFORATORS, REUSABLE EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Türkiye 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
Reusable Surgical Instruments by Hangzhou Rejoin Mastin Medical Device 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 | 69418325P2021036249B | 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 aff0e325-5dd1-4ea2-af8c-a06fc17e27cc 61 fields · synced Jun 20, 2026