Identity
- Trade Name
- CALCINASE-EDTA-Lösung EUDAMED
- Device Name
- CALCINASE EDTA-Solution EUDAMED
- Model / Reference
- 0032301 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 111669957494 EUDAMED
- Basic UDI-DI
- PP01991.LA10.CLB2.ENDO.31 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
CALCINASE-EDTA-Lösung by lege artis Pharma GmbH + Co. KG — 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 | PP01991.LA10.CLB2.ENDO.31 | Class IIa | Active |
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Manufacturer
- Manufacturer
- lege artis Pharma GmbH + Co. KG
- EUDAMED SRN
- DE-MF-000006175
Sources (1)
- EUDAMED e284bfb6-68f9-40ca-adc9-f2f30f98b468 61 fields · synced Oct 8, 2026