Identity
- Trade Name
- DIA-ENDORING EUDAMEDFDA UDI
- Generic Name
- Endodontic instrument chairside holder set FDA UDI
- Device Name
- DIA-ENDORING EUDAMEDA simple & practical design for measuring files. FDA UDI
- Model / Reference
- DIA-ENDORING EUDAMED850-001 EUDAMED- FDA UDI
- Description
- A simple & practical design for measuring files. FDA UDI
Identifiers
- Catalog Number
- 850-001 FDA UDI
- Primary DI / UDI-DI
- 08806383535908 EUDAMEDFDA UDI
- Basic UDI-DI
- 88063835DER3R EUDAMED
- FDA Product Code
- EIL FDA UDI
- EMDN Code
- Q010199 CONSERVATIVE DENTISTRY AND ENDODONTICS DEVICES - OTHER EUDAMED
- GMDN Term
- Endodontic instrument chairside holder set FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 872.4565 FDA UDI
- Market of Registration
- Netherlands EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
Yes
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
Yes
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
No
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Dia-Endoring by Diadent Group International — 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 | 88063835DER3R | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Diadent Group International
- EUDAMED SRN
- KR-MF-000023806
- Authorised Representative
- Diadent Europe B.V. NL-AR-000012597
Sources (2)
- EUDAMED 987de082-5c2a-4243-b29a-cb8da6726714 61 fields · synced Jul 10, 2026
- FDA UDI 68b4d8d5-98d5-451d-9452-5f6ec753fdec 35 fields · synced May 27, 2026