Identity
- Device Name
- Universal RealGUIDE box EUDAMED
- Model / Reference
- 3DM00632 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08050038832120 EUDAMED
- Basic UDI-DI
- 805003883STRLZTNBOX39 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
Universal RealGUIDE box by 3diemme Srl — 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 | 805003883STRLZTNBOX39 | Class I | Active |
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Manufacturer
- Manufacturer
- 3DIEMME srl
- EUDAMED SRN
- IT-MF-000016005
Sources (1)
- EUDAMED 12d61f8e-b5f4-4f48-8c60-ee0c08ba9fd7 61 fields · synced Jun 19, 2026