Identity
- Trade Name
- MANUALEX PRO EUDAMED
- Device Name
- MANUALEX EUDAMED
- Model / Reference
- MANUALEX-PRO EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05906168035623 EUDAMED
- Basic UDI-DI
- 59061680356MANUALEXC8 EUDAMED
- Direct Marketing DI
- 05906168035623 EUDAMED
- EMDN Code
- Z12040299 GENERAL MEDICINE THERAPEUTIC TREATMENT INSTRUMENTS - OTHER EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Poland 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: Dermatological laser beam guiding handpiece
Manualex Pro by Sanimed Jarosław Jędrzejowski — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
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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 | 59061680356MANUALEXC8 | Class I | Active |
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Manufacturer
- Manufacturer
- Sanimed Jarosław Jędrzejowski
- EUDAMED SRN
- PL-MF-000051705
Sources (1)
- EUDAMED 7a29b526-06fb-4411-949c-9170d209073d 61 fields · synced Jul 13, 2026