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Flexible Spatula Wooden Handle 21.5cm
EUDAMEDClass I (EU MDR)
Ref D-118-813Model DENTAL SPATULA
Identity
- Trade Name
- FLEXIBLE SPATULA WOODEN HANDLE 21.5CM EUDAMED
- Device Name
- CEMENT SPATULA , SOLID FIG. 2 EUDAMED
- Model / Reference
- DENTAL SPATULA EUDAMEDD-118-813 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08961104041790 EUDAMED
- Basic UDI-DI
- 896110404DSPATULACLASSIRU EUDAMED
- EMDN Code
- L159013 DENTAL SPATULAS, REUSABLE EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Spain 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
Flexible Spatula Wooden Handle 21.5cm by Mark One Surgical — 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 | 896110404DSPATULACLASSIRU | Class I | Active |
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Manufacturer
- Manufacturer
- Mark One Surgical
- EUDAMED SRN
- PK-MF-000031202
- Authorised Representative
- KHANG BAO INTERNATIONAL KFT HU-AR-000034102
Sources (1)
- EUDAMED 61ba96a7-cafd-45bf-b5be-8b65ed5ee2a8 61 fields · synced Jul 9, 2026