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Prima 2000
EUDAMEDClass IIa (EU MDR)
Ref 100227CRef 100230RORef 100227Ref 100230ITRef 100230
Identity
- Trade Name
- Prima 2000 EUDAMED
- Device Name
- Bonding Agents EUDAMED
- Model / Reference
- 100227C EUDAMED100230RO EUDAMED100227 EUDAMED100230IT EUDAMED100230 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 07290115052671 EUDAMED07290115050929 EUDAMED07290115050097 EUDAMED07290115051186 EUDAMED07290115050110 EUDAMED
- Basic UDI-DI
- 72901150510020094 EUDAMED
- EMDN Code
- Q01010104 DENTAL BONDING AGENTS EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Belgium 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
Category: Dentine bonding agent/set
Prima 2000 by B.J.M. Laboratories Ltd. — Class IIa — MDR — listed in EUDAMED — regulatory data on deviCERTS
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Also classified as Dentine bonding agent/set.
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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 | 72901150510020094 | Class IIa | Active |
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Manufacturer
- Manufacturer
- B.J.M. Laboratories Ltd.
- EUDAMED SRN
- IL-MF-000034121
- Authorised Representative
- Obelis s.a. BE-AR-000000106
Sources (5)
- EUDAMED 3cfea2ba-bbf5-4950-9eaf-cfe1b5ec6330 61 fields · synced Aug 1, 2026
- EUDAMED b712ae61-645a-4f21-9783-a7533a1f2d30 61 fields · synced May 17, 2026
- EUDAMED d8012841-40ca-4482-8682-d5d74f0203a7 61 fields · synced May 18, 2026
- EUDAMED e567fec3-b591-49dc-a833-b724f627c9fc 61 fields · synced May 18, 2026
- EUDAMED 4374a7ba-80d0-474e-a2ef-5b63c6423849 61 fields · synced May 19, 2026