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Phaco pack OS4, 2.8 mm
EUDAMEDClass IIa (EU MDR)
Ref VV660011AE2Model MD0105.13 Surgery Packs OS4 Single UseRef VV660011AEA
Identity
- Trade Name
- Phaco pack OS4, 2.8 mm EUDAMEDPhaco pack OS 4, 2.8mm EUDAMED
- Model / Reference
- MD0105.13 Surgery Packs OS4 Single Use EUDAMEDVV660011AE2 EUDAMEDVV660011AEA EUDAMED
Identifiers
- Primary DI / UDI-DI
- 07630003912838 EUDAMED07630003913088 EUDAMED
- Basic UDI-DI
- 76300039MD010513T5 EUDAMED
- EMDN Code
- Q020601 PHACOEMULSIFICATION SETS EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Austria 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
Phaco pack OS4, 2.8 mm by Oertli Instrumente Ag — 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 | 76300039MD010513T5 | Class IIa | Active |
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Manufacturer
- Manufacturer
- Oertli Instrumente AG
- EUDAMED SRN
- CH-MF-000016175
- Authorised Representative
- Oertli Ophthalmedic Österreich GmbH AT-AR-000003554
Sources (2)
- EUDAMED 99a1e646-1e45-43b0-92a0-1d8b58338a7e 61 fields · synced Jul 10, 2026
- EUDAMED d56fdd3d-45fe-4343-9108-249a55642729 61 fields · synced May 18, 2026