Identity
- Trade Name
- Calciumhydroxid-hochdispers Spritze 1,7 g EUDAMED
- Device Name
- Calciumhydroxid-hochdispers EUDAMED
- Model / Reference
- 79 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 111743956213 EUDAMED
- Basic UDI-DI
- PP05449CAOH2HOCHDISPERS24 EUDAMED
- Direct Marketing DI
- 111743956213 EUDAMED
- EMDN Code
- Q01010199 DENTAL RESTORATION DEVICES - OTHER 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
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
Category: Dental appliance fabrication material, ceramic
Calciumhydroxid-hochdispers Spritze 1, 7 g by Humanchemie GmbH — Class IIa — MDR — listed in EUDAMED — regulatory data on deviCERTS
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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 | PP05449CAOH2HOCHDISPERS24 | Class IIa | Active |
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Manufacturer
- Manufacturer
- Humanchemie GmbH
- EUDAMED SRN
- DE-MF-000005661
Sources (1)
- EUDAMED e10124f9-3776-4b81-8f3a-ac1934903d50 61 fields · synced Jun 18, 2026