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Prime ortho
EUDAMEDClass I (EU MDR)
Ref SAWB/PL-IPRFRef SAWB/PL-PMModel Photographic Mirror -Shape B
Identity
- Trade Name
- Prime ortho EUDAMED
- Device Name
- IPR Files EUDAMEDPhotographic Mirror EUDAMED
- Model / Reference
- SAWB/PL-IPRF EUDAMEDPhotographic Mirror -Shape B EUDAMEDSAWB/PL-PM EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08908018231015 EUDAMED08908018231107 EUDAMED
- Basic UDI-DI
- 89080182313006D EUDAMED890801823163177 EUDAMED
- EMDN Code
- Q010599 DENTAL INSTRUMENTS, SINGLE-USE - OTHER EUDAMEDL160201 DENTAL MIRRORS AND HANDLES, REUSABLE EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Italy EUDAMEDSpain EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMEDEUDAMED
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
Prime ortho by Sawbros Industries Pvt. Ltd. — 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 | 89080182313006D | Class I | Active |
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Manufacturer
- Manufacturer
- Sawbros Industries Pvt. Ltd.
- EUDAMED SRN
- IN-MF-000016702
- Authorised Representative
- Meddevices Lifesciences B.V. NL-AR-000000594
Sources (2)
- EUDAMED 722c6ca6-5469-486c-ac90-047a91c45825 61 fields · synced Jul 26, 2026
- EUDAMED e64df3bd-eb16-48fa-82f1-cac395e121ca 61 fields · synced May 17, 2026