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iSy® Sugery and prosthetic tray
EUDAMEDFDA UDIClass I (EU MDR)
Ref P5330.0110
by ALTATEC GmbH
Identity
- Trade Name
- iSy® Sugery and prosthetic tray EUDAMEDiSy® Surgery and prosthetic tray FDA UDI
- Generic Name
- Instrument tray, reusable FDA UDI
- Device Name
- iSy® Surgery and prosthetic set EUDAMEDiSy® Surgery and prosthetic tray FDA UDI
- Model / Reference
- P5330.0110 EUDAMEDFDA UDI
- Description
- iSy® Surgery and prosthetic tray FDA UDI
Identifiers
- Catalog Number
- P5330.0110 FDA UDI
- Primary DI / UDI-DI
- 04099797022100 EUDAMEDE219P533001101 FDA UDI
- Basic UDI-DI
- 40997970008210000000000KJ EUDAMED
- Secondary DI
- E219P533001101 EUDAMED
- FDA Product Code
- FSM FDA UDI
- EMDN Code
- Z12110180 INSTRUMENTS FOR DENTAL TREATMENT UNITS - HARDWARE ACCESSORIES EUDAMED
- GMDN Term
- Instrument tray, reusable FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 878.4800 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
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
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
iSy® Sugery and prosthetic tray by ALTATEC GmbH — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 40997970008210000000000KJ | Class I | Active |
| EUDAMED | European Union | CE/MDR | 40997970008210000000000KJ | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- ALTATEC GmbH
- EUDAMED SRN
- DE-MF-000006230
Sources (2)
- EUDAMED 29c65748-d6a2-47c5-8966-b18e95f9644b 61 fields · synced May 31, 2026
- FDA UDI 1d54c3a3-f71f-4feb-be77-4b75691b1819 35 fields · synced May 30, 2026