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Calxyl® X-Ray Visible
EUDAMEDClass IIa (EU MDR)
Ref 11400200Model CALXYL® X-RAY VISIBLE
by OCO-Präparate Herstellung und Vertrieb von pharmazeutischen Produkten GmbH
Identity
- Trade Name
- CALXYL® X-RAY VISIBLE EUDAMED
- Device Name
- CALXYL® X-RAY VISIBLE EUDAMED
- Model / Reference
- CALXYL® X-RAY VISIBLE EUDAMED11400200 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04260741310059 EUDAMED
- Basic UDI-DI
- B-04260741310059 EUDAMED
- EMDN Code
- Q01010201 ROOT CANAL FILLING DENTAL PASTES EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
Yes
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Category: Dental coating, tooth-desensitizing
Calxyl® X-Ray Visible by OCO-Präparate Herstellung und Vertrieb von pharmazeutischen Produkten GmbH — Class IIa — MDD — listed in EUDAMED
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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-04260741310059 | Class IIa | Active |
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Manufacturer
- EUDAMED SRN
- DE-MF-000012362
Sources (1)
- EUDAMED 0d07abac-822e-40e2-97ab-d0f0776d46b9 61 fields · synced Jun 19, 2026