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Instrument Kit: S1 Platform E/ F/ G
EUDAMEDClass I (EU MDR)
Ref 1736
by Integrum AB
Identity
- Trade Name
- Instrument Kit: S1 Platform E/ F/ G EUDAMED
- Device Name
- OPRA Implant System Instruments - OPRA Instrument Kits EUDAMED
- Model / Reference
- 1736 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 07340152100399 EUDAMED
- Basic UDI-DI
- 73401521RUinstrumentkit4A EUDAMED
- Direct Marketing DI
- 07340152100399 EUDAMED
- EMDN Code
- L0399 GENERAL SURGERY INSTRUMENTS, REUSABLE - OTHER EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Sweden 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
Instrument Kit: S1 Platform E/ F/ G by Integrum AB — 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 | 73401521RUinstrumentkit4A | Class I | Active |
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Manufacturer
- Manufacturer
- Integrum AB
- EUDAMED SRN
- SE-MF-000026900
Sources (1)
- EUDAMED 37f036a1-e98d-4e50-b1fa-53ca0ddd332e 61 fields · synced Jul 9, 2026