Identity
- Trade Name
- Smiles & Styles Enterprises EUDAMED
- Device Name
- Lester Lens Manipulator – angled -Titanium EUDAMED
- Model / Reference
- M0002 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08964004694905 EUDAMED
- Basic UDI-DI
- 8964004694M00022L EUDAMED
- EMDN Code
- Q020203 CORNEAL MARKERS EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Poland EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMED
Implantable
No
EUDAMED
Reusable
Yes
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: Corneal marker, reusable
Smiles & Styles Enterprises by Smiles & Styles Enterprises — 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 | 8964004694M00022L | Class I | Active |
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Manufacturer
- Manufacturer
- Smiles & Styles Enterprises
- EUDAMED SRN
- PK-MF-000049684
- Authorised Representative
- KHANG BAO INTERNATIONAL KFT HU-AR-000034102
Sources (1)
- EUDAMED 7d50fc0b-9570-46c7-8baa-2a0943f22f3f 61 fields · synced Jul 16, 2026