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Complete Set With 4rings
EUDAMEDClass I (EU MDR)
Ref 47-135-00Model 47-120-01 TO 47-164-19
Identity
- Trade Name
- COMPLETE SET WITH 4RINGS EUDAMED
- Device Name
- ORAL INSTRUMENTS EUDAMED
- Model / Reference
- 47-120-01 TO 47-164-19 EUDAMED47-135-00 EUDAMED
Identifiers
- Primary DI / UDI-DI
- +G164471350002 EUDAMED
- Basic UDI-DI
- ++G1644712001to471XX EUDAMED
- EMDN Code
- L03140199 SPREADERS AND RETRACTORS FOR GENERAL SURGERY, REUSABLE - 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
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Category: Hand-held surgical retractor, reusable
Complete Set With 4rings by Eltek Instruments Pvt 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 | ++G1644712001to471XX | Class I | Active |
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Manufacturer
- Manufacturer
- Eltek Instruments Pvt Ltd
- EUDAMED SRN
- PK-MF-000024315
- Authorised Representative
- CS Active LV-AR-000011602
Sources (1)
- EUDAMED 2ae61639-656c-46c0-bc76-c4cdcf1c508a 61 fields · synced Jul 9, 2026