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Disposable Casing Set
EUDAMEDClass IIa (EU MDR)
Ref 510.701.220Model Procedure Pack for Corneal Surgery 8.5 mm
Identity
- Trade Name
- Disposable Casing Set EUDAMED
- Device Name
- Procedure Pack for Corneal Surgery 8.5 mm EUDAMED
- Model / Reference
- Procedure Pack for Corneal Surgery 8.5 mm EUDAMED510.701.220 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 07640167751594 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
- Czechia 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
Disposable Casing Set by SIE AG, Surgical Instrument Engineering — Class IIa — MDR — listed in EUDAMED — regulatory data on deviCERTS
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 f32c5653-ec5a-4f49-bbaf-11e9340f1524 61 fields · synced Jun 19, 2026