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iSy® Titanium base CAD/CAM
EUDAMEDClass IIb (EU MDR)
Ref P2344.5020Ref P2344.4420Ref P2344.5008
by ALTATEC GmbH
Identity
- Trade Name
- iSy® Titanium base CAD/CAM EUDAMED
- Device Name
- iSy® Abutments EUDAMED
- Model / Reference
- P2344.5020 EUDAMEDP2344.4420 EUDAMEDP2344.5008 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04099797021202 EUDAMED04099797021189 EUDAMED04099797021196 EUDAMED
- Basic UDI-DI
- 40997970001901000000000JL EUDAMED
- Secondary DI
- E219P234450201 EUDAMEDE219P234444201 EUDAMEDE219P234450081 EUDAMED
- EMDN Code
- P01020180 DENTAL IMPLANTS - ACCESSORIES EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
No
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® Titanium base CAD/CAM 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 | 40997970001901000000000JL | Class IIb | Active |
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Manufacturer
- Manufacturer
- ALTATEC GmbH
- EUDAMED SRN
- DE-MF-000006230
Sources (3)
- EUDAMED 8d2739d8-9e0c-4dbf-b370-c72e79ac1053 61 fields · synced Jul 30, 2026
- EUDAMED 56b2e4e8-6832-4109-ac95-7275bda35204 61 fields · synced May 18, 2026
- EUDAMED 589d2f19-763e-4b85-994c-89776fa5d3b7 61 fields · synced May 18, 2026