Identity
- Trade Name
- Retractors (Non-Surgical) EUDAMED
- Device Name
- Retractors (Non-Surgical) EUDAMED
- Model / Reference
- 06-163 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08964004479632 EUDAMED
- Basic UDI-DI
- 89640031761717S 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
Retractors (Non-Surgical) by Formed Surgical Instruments — 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 | 89640031761717S | Class I | Active |
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Manufacturer
- Manufacturer
- Formed Surgical Instruments
- EUDAMED SRN
- PK-MF-000011695
- Authorised Representative
- International Business Compendious of Sweden SE-AR-000001625
Sources (1)
- EUDAMED 57483a7b-7fd9-4039-a23e-0be1b908681a 61 fields · synced Jul 19, 2026