Identity
- Trade Name
- Pattern EUDAMED
- Device Name
- iSy® Surgery Trays EUDAMED
- Model / Reference
- P5300.1090 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04099797021660 EUDAMED
- Basic UDI-DI
- 40997970008211000000000LF EUDAMED
- Secondary DI
- E219P530010901 EUDAMED
- EMDN Code
- Z12110180 INSTRUMENTS FOR DENTAL TREATMENT UNITS - HARDWARE ACCESSORIES EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Germany 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
Pattern by ALTATEC GmbH — 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 | 40997970008211000000000LF | Class I | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- ALTATEC GmbH
- EUDAMED SRN
- DE-MF-000006230
Sources (1)
- EUDAMED db8d6bf1-9ca4-4132-b32d-1850392e6689 61 fields · synced Jun 18, 2026