Identity
- Device Name
- Dental Instruments Scaler and Probe EUDAMED
- Model / Reference
- DT-99001-1 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08964000797082 EUDAMED
- Basic UDI-DI
- B-08964000797082 EUDAMED
- EMDN Code
- Q010508 DENTAL SURGERY INSTRUMENT KITS, SINGLE-USE EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Austria EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
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
Dental Instruments Scaler and Probe by Electro Range MFG Co — Class I — 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-08964000797082 | Class I | Active |
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Manufacturer
- Manufacturer
- Electro Range MFG Co
- EUDAMED SRN
- PK-MF-000036519
- Authorised Representative
- European Healthcare & Device Solutions Ltd. IE-AR-000003999
Sources (1)
- EUDAMED 10a9bdad-e473-457a-9179-32ea82f5dbcc 61 fields · synced Oct 8, 2026