Identity
- Device Name
- Spatula EUDAMED
- Model / Reference
- 1 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08964004821073 EUDAMED
- Basic UDI-DI
- 896400482108J4 EUDAMED
- EMDN Code
- Q01020202 SPRAY AND LIQUID DENTAL CONTACT INDICATORS EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Austria EUDAMED
Clinical & Handling
Sterile
Yes
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
Spatula by Burhan Kamran Industries — 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 | 896400482108J4 | Class I | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Burhan Kamran Industries
- EUDAMED SRN
- PK-MF-000052581
- Authorised Representative
- EU-UK AUTHORISED REPRESENTATIVE LIMITED XI-AR-000047163
Sources (1)
- EUDAMED ba1c4f29-2d1b-468b-9e7e-af471de3f571 61 fields · synced Jul 28, 2026