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Optilet Mini nakłuwacz
EUDAMEDClass I (EU MDR)
Ref 5221Model Optilet PRO, Optilet MINI
Identity
- Trade Name
- Optilet Mini nakłuwacz EUDAMED
- Device Name
- Lancing device EUDAMED
- Model / Reference
- Optilet PRO, Optilet MINI EUDAMED5221 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05907581254028 EUDAMED
- Basic UDI-DI
- 590758125lancetdeviceAZ EUDAMED
- EMDN Code
- A018099 NEEDLES - OTHER ACCESSORIES 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: Electromagnetic surgical navigation device tracking system
Optilet Mini nakłuwacz by Diagnosis S.a. — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
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Also classified as Electromagnetic surgical navigation device tracking system.
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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 | 590758125lancetdeviceAZ | Class I | Active |
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Manufacturer
- Manufacturer
- Diagnosis S.a.
- EUDAMED SRN
- PL-MF-000014187
Sources (1)
- EUDAMED 80fc974e-50bb-4517-9559-3d4a8e6f433f 61 fields · synced Jun 18, 2026