Identity
- Trade Name
- Opalescence Endo EUDAMED
- Device Name
- Opalescence Endo EUDAMED
- Model / Reference
- 1323 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00883205104090 EUDAMED
- Basic UDI-DI
- 0883205-TF026AV EUDAMED
- EMDN Code
- Q010199 CONSERVATIVE DENTISTRY AND ENDODONTICS DEVICES - OTHER EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
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
Opalescence Endo by Ultradent Products, Inc. — Class IIa — 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 | 0883205-TF026AV | Class IIa | Active |
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Manufacturer
- Manufacturer
- Ultradent Products, Inc.
- EUDAMED SRN
- US-MF-000013697
- Authorised Representative
- Ultradent Products GmbH DE-AR-000006666
Sources (1)
- EUDAMED 13060744-005f-4964-b438-ac27ae856f93 61 fields · synced Jun 19, 2026