Identity
- Trade Name
- Augenmarker EUDAMED
- Device Name
- Augenmarker EUDAMED
- Model / Reference
- 1832-A-0001 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06430074264062 EUDAMED
- Basic UDI-DI
- 6430074263997WQ EUDAMED
- EMDN Code
- Q020203 CORNEAL MARKERS EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Germany 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: Corneal marker, reusable
Augenmarker by Mekalasi Oy — 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 | 6430074263997WQ | Class I | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Mekalasi Oy
- EUDAMED SRN
- FI-MF-000003102
Sources (1)
- EUDAMED 3ff57fb4-ab21-4929-aa07-f44af0dbacaf 61 fields · synced Jul 29, 2026