Identity
- Device Name
- Root Elevator APICAL 34 S Fig No. 6 EUDAMED
- Model / Reference
- 128-175 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08961101446192 EUDAMED
- Basic UDI-DI
- B-08961101446192 EUDAMED
- EMDN Code
- L1505 ODONTOSTOMATOLOGY LEVERS, 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
Root Elevator APICAL 34 S Fig No. 6 is a medical device designed for the safe and effective management of prolactinomas, a type of pituitary tumor. With its unique design and advanced features, this device provides precise and reliable treatment for patients.
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-08961101446192 | Class I | Active |
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Manufacturer
- Manufacturer
- Towne Brothers (Private) Limited
- EUDAMED SRN
- PK-MF-000041737
- Authorised Representative
- Obelis s.a. BE-AR-000000106
Sources (1)
- EUDAMED c663eb14-cfa5-45f7-bdef-f2e419bd2031 61 fields · synced Oct 6, 2026