Identity
- Trade Name
- EXACTA RS: Instruments Tray - Empty EUDAMED
- Device Name
- Instruments Tray EUDAMED
- Model / Reference
- S13210 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08050323111985 EUDAMED
- Basic UDI-DI
- 8050323I0001AZV EUDAMED
- Direct Marketing DI
- 08050323111985 EUDAMED
- EMDN Code
- S010401 TRAYS, BASKETS, TUBS FOR STERILISATION AND THEIR COMPONENTS EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Italy EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
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: Instrument tray, reusable
EXACTA RS: Instruments Tray - Empty by Permedica S.p.A — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
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Also classified as Instrument tray, reusable.
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- ASELTECH — Asel Tibbi Aletler A.S. · Class I
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 | 8050323I0001AZV | Class I | Active |
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Manufacturer
- Manufacturer
- Permedica S.p.A
- EUDAMED SRN
- IT-MF-000008110
Sources (1)
- EUDAMED a316b60e-ccb2-4a31-8e4a-3c53f54978ea 61 fields · synced Jun 18, 2026