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iSy® Multi-unit Abutment
EUDAMEDClass IIb (EU MDR)
Ref P2254.4840Ref P2266.4820Ref P2268.4820Ref P2254.4830
by ALTATEC GmbH
Identity
- Trade Name
- iSy® Multi-unit Abutment EUDAMED
- Device Name
- iSy® Abutments EUDAMED
- Model / Reference
- P2254.4840 EUDAMEDP2266.4820 EUDAMEDP2268.4820 EUDAMEDP2254.4830 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04099797020984 EUDAMED04099797021035 EUDAMED04099797021066 EUDAMED04099797020977 EUDAMED
- Basic UDI-DI
- 40997970001901000000000JL EUDAMED
- Secondary DI
- E219P225448401 EUDAMEDE219P226648201 EUDAMEDE219P226848201 EUDAMEDE219P225448301 EUDAMED
- EMDN Code
- P01020180 DENTAL IMPLANTS - ACCESSORIES 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® Multi-unit Abutment 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 (4)
- EUDAMED aaf2d8a5-1999-4bc8-828b-e45cf8ca0f55 61 fields · synced Sep 18, 2026
- EUDAMED 835ba4ac-d9e4-4b41-a6dd-6fc4528f503d 61 fields · synced May 17, 2026
- EUDAMED 5cc31f64-eaae-4dbe-929b-5dcf2f6790a8 61 fields · synced May 17, 2026
- EUDAMED 10f747fc-479c-4b05-a8fb-8d150c0bb7dc 61 fields · synced May 19, 2026