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Wurzelkanal-Erweiterer "Peeso"
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref 183.15.204.170Model 16411
Identity
- Trade Name
- Wurzelkanal-Erweiterer "Peeso" EUDAMEDEDENTA FDA UDI
- Generic Name
- Endodontic enlarger, reusable FDA UDI
- Device Name
- Endo-Instrumente EUDAMEDRoot canal reamers "Peeso" FDA UDI
- Model / Reference
- 16411 EUDAMED183.15.204.170 EUDAMEDFDA UDI
- Description
- Root canal reamers "Peeso" FDA UDI
Identifiers
- Catalog Number
- EP204-170 FDA UDI
- Primary DI / UDI-DI
- E312183152041701 EUDAMEDFDA UDI
- Basic UDI-DI
- ++E31216411DS EUDAMED
- Unit of Use DI
- E31218315204170101 EUDAMED
- FDA Product Code
- DZA FDA UDI
- EMDN Code
- L159004 ENDODONTIC RASPS AND FILES, REUSABLE EUDAMED
- GMDN Term
- Endodontic enlarger, reusable FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass I FDA UDI
- Regulation Number
- 872.4130 FDA UDI
- Market of Registration
- Liechtenstein EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
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
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Wurzelkanal-Erweiterer "Peeso" by Edenta Etablissement — Class IIa — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | ++E31216411DS | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- Edenta Etablissement
- EUDAMED SRN
- LI-MF-000011937
Sources (2)
- EUDAMED 40b3d084-8653-42e5-9b01-5824e321133f 61 fields · synced Jul 25, 2026
- FDA UDI e194ca40-fffe-4b6a-9368-7f0f24b9e833 34 fields · synced May 30, 2026