Identity
- Trade Name
- iSy® Implant EUDAMED
- Device Name
- iSy® Implant snap-in EUDAMED
- Model / Reference
- P1120.5009 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04099797020304 EUDAMED
- Basic UDI-DI
- 40997970000604000000000GK EUDAMED
- Secondary DI
- E219P112050091 EUDAMED
- EMDN Code
- P01020101 DENTAL IMPLANTS EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMED
Implantable
Yes
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
Sutures
Yes
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
iSy® Implant by ALTATEC GmbH — Class IIb — 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 | 40997970000604000000000GK | Class IIb | Active |
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Manufacturer
- Manufacturer
- ALTATEC GmbH
- EUDAMED SRN
- DE-MF-000006230
Sources (1)
- EUDAMED 82499c32-0af1-4af9-8b55-3a865555d245 61 fields · synced May 23, 2026