Identity
- Trade Name
- Reusable Syringe Gun EUDAMED
- Device Name
- Bone Cement Mixer Syringe - Reusable Syringe Gun EUDAMED
- Model / Reference
- 5000-12 EUDAMED9753000 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06973181640812 EUDAMED
- Basic UDI-DI
- B-06973181640812 EUDAMED
- EMDN Code
- A03040299 IRRIGATION KITS, SINGLE-USE - OTHER EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Belgium EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Reusable Syringe Gun by Dongguan Kaiser Technology Co., Ltd. — Class I — MDD — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-06973181640812 | Class I | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Dongguan Kaiser Technology Co., Ltd.
- EUDAMED SRN
- CN-MF-000006968
- Authorised Representative
- MedNet EC-REP GmbH DE-AR-000000002
Sources (1)
- EUDAMED af19a21d-fb53-4373-ab63-653906d1ac45 61 fields · synced Jul 8, 2026