Identity
- Device Name
- Scaler 204SD Standard 8mm hollow handle EUDAMED
- Model / Reference
- 401/204SD EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08961101441012 EUDAMED
- Basic UDI-DI
- B-08961101441012 EUDAMED
- EMDN Code
- L159009 ODONTOSTOMATOLOGY SCALERS, REUSABLE EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Austria EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
Yes
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
Scaler 204SD Standard 8mm hollow handle by Towne Brothers (Private) Limited — 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-08961101441012 | Class I | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Towne Brothers (Private) Limited
- EUDAMED SRN
- PK-MF-000041737
- Authorised Representative
- Obelis s.a. BE-AR-000000106
Sources (1)
- EUDAMED 99cd7780-93b3-4edf-b27a-d854db6373ff 61 fields · synced Oct 8, 2026