Identity
- Trade Name
- Julius Wirth EUDAMED
- Model / Reference
- Dental Device EUDAMED301-008 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00810036783774 EUDAMED
- Basic UDI-DI
- 08100367835850GH EUDAMED
- EMDN Code
- Q010207 DENTAL IMPRESSION DEVICES FOR PROSTHETIC DENTISTRY EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Netherlands EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
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
Julius Wirth by J&J Instruments, LLC — 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 | 08100367835850GH | 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 f9e64ccd-d748-4753-9540-0baa279b02eb 61 fields · synced Jun 19, 2026