Identity
- Trade Name
- Irishäkchen EUDAMED
- Device Name
- Irishäkchen n. Dardenne, push-pull EUDAMED
- Model / Reference
- Irishäkchen EUDAMEDEC111383 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04251972728690 EUDAMED
- Basic UDI-DI
- 42519727Instr-Manipuli.WQ EUDAMED
- Direct Marketing DI
- 04251972728690 EUDAMED
- EMDN Code
- Q021104 OPHTHALMIC SURGERY MANIPULATORS, SINGLE-USE EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Germany 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: Ophthalmic surgical probe, single-use
Irishäkchen by eye concept GmbH — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
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Also classified as Ophthalmic surgical probe, single-use.
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- Epithelial Spatula — BLINK MEDICAL LIMITED · 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 | 42519727Instr-Manipuli.WQ | Class I | Active |
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Manufacturer
- Manufacturer
- eye concept GmbH
- EUDAMED SRN
- DE-MF-000023676
Sources (1)
- EUDAMED c185ec76-75e6-48c4-bd02-051f5756b3f9 61 fields · synced Jul 8, 2026