Identity
- Trade Name
- Grisdale Bone Condenser, 1.7mm - 2.0mm EUDAMED
- Device Name
- 8964004872570DI05228P8 EUDAMED
- Model / Reference
- DI-05-228 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08964004872570 EUDAMED
- Basic UDI-DI
- 8964004872570DI05228P8 EUDAMED
- EMDN Code
- Q01010199 DENTAL RESTORATION DEVICES - OTHER EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
Yes
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
Grisdale Bone Condenser, 1.7mm - 2.0mm by Zasber International — Class I — 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 | 8964004872570DI05228P8 | Class I | Active |
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Manufacturer
- Manufacturer
- Zasber International
- EUDAMED SRN
- PK-MF-000046743
- Authorised Representative
- Yousfis S.L. ES-AR-000041900
Sources (1)
- EUDAMED 1b8ab2b3-bb38-4d43-b2d9-244f7dec7bc2 61 fields · synced Jul 17, 2026