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NobelZygoma™ 45° Ext Hex TiUltra™ RP 4.0x57.5mm
EUDAMEDClass IIb (EU MDR)
Ref 301565
Identity
- Trade Name
- NobelZygoma™ 45° Ext Hex TiUltra™ RP 4.0x57.5mm EUDAMED
- Device Name
- Zygomatic implants EUDAMED
- Model / Reference
- 301565 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 07332747197952 EUDAMED
- Basic UDI-DI
- 73327470000000016C EUDAMED
- EMDN Code
- P01020101 DENTAL IMPLANTS EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- Sweden 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
NobelZygoma™ 45° Ext Hex TiUltra™ RP 4.0x57.5mm by Nobel Biocare AB — 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 | 73327470000000016C | Class IIb | Active |
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Manufacturer
- Manufacturer
- Nobel Biocare AB
- EUDAMED SRN
- SE-MF-000000009
Sources (1)
- EUDAMED b13b0eed-f6e6-42ac-b013-4bf142311a65 61 fields · synced Jul 13, 2026