Identity
- Trade Name
- Julius Wirth EUDAMED
- Model / Reference
- Dental Device EUDAMED737-003 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00810036783613 EUDAMED
- Basic UDI-DI
- 08100367831878GB EUDAMED
- EMDN Code
- L159004 ENDODONTIC RASPS AND FILES, REUSABLE EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Netherlands 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
Category: Manual endodontic file/rasp, reusable
Julius Wirth by J&J Instruments, LLC — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
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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 | 08100367831878GB | Class I | Active |
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Manufacturer
- Manufacturer
- J&J Instruments, LLC
- EUDAMED SRN
- US-MF-000008974
- Authorised Representative
- Emergo Europe B.V. NL-AR-000000116
Sources (1)
- EUDAMED 62b7fbaa-a559-4ee3-b8b3-2a8e7856d153 61 fields · synced Jun 19, 2026