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NobelPearl™ Prosthetic Kit Inter-X Box
EUDAMEDFDA UDIClass I (EU MDR)
Ref 300771
Identity
- Trade Name
- NobelPearl™ Prosthetic Kit Inter-X Box EUDAMEDNobelPearl Prosthetic Kit Inter-X Box FDA UDI
- Generic Name
- Instrument tray, reusable FDA UDI
- Device Name
- Instrument trays EUDAMEDTools FDA UDI
- Model / Reference
- 300771 EUDAMEDFDA UDI
- Description
- Tools FDA UDI
Identifiers
- Catalog Number
- 300771 FDA UDI
- Primary DI / UDI-DI
- 07640161393660 EUDAMEDFDA UDI
- Basic UDI-DI
- 764016139XX488YYK01SUU7 EUDAMED
- FDA Product Code
- NDP FDA UDI
- EMDN Code
- V0402 CLINICAL USE TRAYS AND BOWLS EUDAMED
- GMDN Term
- Instrument tray, reusable FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 872.3980 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
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
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
NobelPearl™ Prosthetic Kit Inter-X Box by CeramTec Schweiz GmbH — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 764016139XX488YYK01SUU7 | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- CeramTec Schweiz GmbH
- EUDAMED SRN
- CH-MF-000024169
- Authorised Representative
- CeramTec Dentalvertriebs GmbH DE-AR-000020220
Sources (2)
- EUDAMED f1a20de5-58e1-411a-8333-fc887bc4f9f6 61 fields · synced Jul 9, 2026
- FDA UDI 09f178cb-a934-45c3-b257-1459082a7144 36 fields · synced May 30, 2026