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Phaco pack OS 4 , 2.2mm
EUDAMEDClass IIa (EU MDR)
Ref VV660011DA2Model MD0105.13 Surgery Packs OS4 Single UseRef VV660011DCRef VV660011DRef VV660011DD2Ref VV660011DA
Identity
- Trade Name
- Phaco pack OS 4 , 2.2mm EUDAMEDPhaco pack OS 4, 2.2mm EUDAMED
- Model / Reference
- MD0105.13 Surgery Packs OS4 Single Use EUDAMEDVV660011DA2 EUDAMEDVV660011DC EUDAMEDVV660011D EUDAMEDVV660011DD2 EUDAMEDVV660011DA EUDAMED
Identifiers
- Primary DI / UDI-DI
- 07630003915464 EUDAMED07630003912852 EUDAMED07630003911497 EUDAMED07630003914979 EUDAMED07630003912821 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 OS 4 , 2.2mm 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 (5)
- EUDAMED 76d394f2-b8f8-4636-bb95-2e7b905a37b2 61 fields · synced Sep 17, 2026
- EUDAMED 3c214330-bc0a-4f3b-b610-be542a636d4e 61 fields · synced May 17, 2026
- EUDAMED 4337082c-e0d2-4786-b73c-cc1e862fd018 61 fields · synced May 17, 2026
- EUDAMED ea2b70c9-e062-4156-860c-f41a5afe80a5 61 fields · synced May 18, 2026
- EUDAMED c0f98f74-3c2c-4994-a168-d8e84f2e13c1 61 fields · synced May 19, 2026