Identity
- Trade Name
- P.K. Thomas Waxing Instrument, #PKT 4 EUDAMED
- Device Name
- P.K. Thomas Waxing Instrument, #PKT 4 EUDAMED
- Model / Reference
- DI-07-103 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08964004873058 EUDAMED
- Basic UDI-DI
- 8964004873058DI07103NR EUDAMED
- EMDN Code
- L15900699 DENTAL MATERIAL PROCESSING INSTRUMENTS, REUSABLE - 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
P.K. Thomas Waxing Instrument, #PKT 4 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 | 8964004873058DI07103NR | 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 9bf5ca4b-35a6-4e65-9e34-cf133addfb37 61 fields · synced Jun 11, 2026