Identity
- Trade Name
- Smiles & Styles Enterprises EUDAMED
- Device Name
- Horizontal Chopper EUDAMED
- Model / Reference
- CH0024 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08964004694981 EUDAMED
- Basic UDI-DI
- 8964004694CH002447 EUDAMED
- EMDN Code
- Q020203 CORNEAL MARKERS EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Poland EUDAMED
Clinical & Handling
Sterile
No
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
Similar devices
Also classified as Corneal marker, reusable.
- Millennium — AVALIGN TECHNOLOGIES, Inc. · Class I
- MR PHACO — Crestpoint Management Ltd. · Class I
- ICHIKAWA OPTIC ZONE MARKER — Katena Products, Inc. · Class I
- SLADE ARCUATE MARKER 45 DEGREE — Katena Products, Inc. · Class I
- Hoffer Optic Zone Marker, with Cross Hairs, 3.0mm — KATALYST SURGICAL, LLC · Class I
- Marker, Ocular — Katena Products, Inc. · Class I
- Double End Martinel Corneal Dissector — DAUD JEE MFG. CO · Class I
- Millennium — AVALIGN TECHNOLOGIES, Inc. · Class I
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 | 8964004694CH002447 | Class I | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Smiles & Styles Enterprises
- EUDAMED SRN
- PK-MF-000049684
- Authorised Representative
- KHANG BAO INTERNATIONAL KFT HU-AR-000034102
Sources (1)
- EUDAMED 4b35fe7b-9e23-43fe-8c40-16325e194666 61 fields · synced Aug 4, 2026