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LCS InterShields d360 µm
EUDAMEDClass IIa (EU MDR)
Ref 510.710.214Model Procedure Pack for Corneal Surgery 8.5 mm
Identity
- Trade Name
- LCS InterShields d360 µm EUDAMED
- Device Name
- Procedure Pack for Corneal Surgery 8.5 mm EUDAMED
- Model / Reference
- Procedure Pack for Corneal Surgery 8.5 mm EUDAMED510.710.214 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 07640167750283 EUDAMED
- Basic UDI-DI
- 764016775PPACKSKP EUDAMED
- EMDN Code
- V0599 CLINICAL PROCEDURES KITS NOT INCLUDED IN OTHER CLASSES - OTHER EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- France EUDAMED
Clinical & Handling
Sterile
Yes
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: Ophthalmic surgical procedure kit, non-medicated, single-use
LCS InterShields d360 µm by SIE AG, Surgical Instrument Engineering — Class IIa — MDR — listed in EUDAMED — regulatory data on deviCERTS
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Also classified as Ophthalmic surgical procedure kit, non-medicated, single-use.
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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 | 764016775PPACKSKP | Class IIa | Active |
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Manufacturer
- Manufacturer
- SIE AG, Surgical Instrument Engineering
- EUDAMED SRN
- CH-MF-000025018
- Authorised Representative
- Ziemer Ophthalmology (DE) GmbH DE-AR-000005638
Sources (1)
- EUDAMED fe5e0499-655e-4f54-b0e4-cca79cf03cf8 61 fields · synced Jul 27, 2026