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Phaco tip easyTip 2.2 mm
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref VV800735AModel MD0105.121 Phaco Tips ReusableRef VV806835A2Model MD0105.21 Phaco Tips Single Use
Identity
- Trade Name
- Phaco tip easyTip 2.2 mm EUDAMEDOertli® FDA UDI
- Generic Name
- Phacoemulsification system handpiece tip, reusable FDA UDI
- Device Name
- TITANSPITZE EASYTIP 2.2MM 30°; PHACO TIP EASYTIP 2.2MM 30°; POINTE PHACO EASYTIP 2.2MM 30° FDA UDI
- Model / Reference
- MD0105.121 Phaco Tips Reusable EUDAMEDVV800735A EUDAMEDFDA UDIMD0105.21 Phaco Tips Single Use EUDAMEDVV806835A2 EUDAMED
- Description
- TITANSPITZE EASYTIP 2.2MM 30°; PHACO TIP EASYTIP 2.2MM 30°; POINTE PHACO EASYTIP 2.2MM 30° FDA UDI
Identifiers
- Primary DI / UDI-DI
- 07630003910315 EUDAMEDFDA UDI07630003915426 EUDAMED
- Basic UDI-DI
- 76300039MD0105121V3 EUDAMED76300039MD010521T4 EUDAMED
- Direct Marketing DI
- 07630003910315 EUDAMED
- FDA Product Code
- HQC FDA UDI
- EMDN Code
- Q020699 PHACOEMULSIFICATION DEVICES - OTHER EUDAMED
- GMDN Term
- Phacoemulsification system handpiece tip, reusable FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 886.4670 FDA UDI
- Market of Registration
- Austria EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDIEUDAMED
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
Yes
EUDAMEDEUDAMED
Contains Latex
No
EUDAMEDFDA UDI
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
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Phaco tip easyTip 2.2 mm by Oertli Instrumente Ag — Class IIa — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 76300039MD0105121V3 | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- Oertli Instrumente AG
- EUDAMED SRN
- CH-MF-000016175
- Authorised Representative
- Oertli Ophthalmedic Österreich GmbH AT-AR-000003554
Sources (3)
- EUDAMED 609d429b-870d-4d7e-9301-b7ec253c74ec 61 fields · synced Jul 31, 2026
- EUDAMED f5f2064e-f068-4db4-bcff-05ff5cbc8ce2 61 fields · synced May 19, 2026
- FDA UDI bf58815d-ff64-4857-80d2-e92d6706abb6 34 fields · synced May 30, 2026