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iSy® Re-Set Removal set
EUDAMEDClass IIa (EU MDR)
Ref P5900.0050
by ALTATEC GmbH
Identity
- Trade Name
- iSy® Re-Set Removal set EUDAMED
- Device Name
- iSy® Re-Set EUDAMED
- Model / Reference
- P5900.0050 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04099797022131 EUDAMED
- Basic UDI-DI
- 40997970004029000000000M8 EUDAMED
- Secondary DI
- E219P590000501 EUDAMED
- EMDN Code
- Z12110180 INSTRUMENTS FOR DENTAL TREATMENT UNITS - HARDWARE ACCESSORIES EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
CMR Substance
Yes
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
iSy® Re-Set Removal set by ALTATEC GmbH — Class IIa — 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 | 40997970004029000000000M8 | Class IIa | Active |
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Manufacturer
- Manufacturer
- ALTATEC GmbH
- EUDAMED SRN
- DE-MF-000006230
Sources (1)
- EUDAMED 492101a6-27ae-433c-b3c5-9726a2128726 61 fields · synced Jun 19, 2026