Identity
- Trade Name
- Henry Schein EUDAMED
- Device Name
- Rotary NiTi file U Coro CX orange 19mm EUDAMED
- Model / Reference
- TF-123 EUDAMED5723930 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 10304040180539 EUDAMED
- Basic UDI-DI
- B-10304040180539 EUDAMED
- EMDN Code
- Q010407 ORTHODONTIC CEMENTS 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
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
Henry Schein by Henry Schein, Inc. — Class IIa — MDD — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-10304040180539 | Class IIa | Active |
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Manufacturer
- Manufacturer
- Henry Schein Inc.
- EUDAMED SRN
- US-MF-000021683
- Authorised Representative
- Henry Schein Services GmbH DE-AR-000008001
Sources (1)
- EUDAMED 6326a3e2-d05c-4afb-aa70-54f231a0381f 61 fields · synced Jul 15, 2026