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Irrigation sleeve CO-MICS
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref VV603231Model MD0105.124 Sleeves Reusable
Identity
- Trade Name
- Irrigation sleeve CO-MICS EUDAMEDOertli® FDA UDI
- Generic Name
- Phacoemulsification system handpiece tip, reusable FDA UDI
- Device Name
- IRRIGATIONSAUFSATZ EASY COMICS; IRRIGATION SLEEVE CO-MICS TIP; MANCHON IRRIGATION CO-MICS FDA UDI
- Model / Reference
- MD0105.124 Sleeves Reusable EUDAMEDVV603231 EUDAMEDFDA UDI
- Description
- IRRIGATIONSAUFSATZ EASY COMICS; IRRIGATION SLEEVE CO-MICS TIP; MANCHON IRRIGATION CO-MICS FDA UDI
Identifiers
- Primary DI / UDI-DI
- 07630003909982 EUDAMEDFDA UDI
- Basic UDI-DI
- 76300039MD0105124V9 EUDAMED
- Direct Marketing DI
- 07630003909982 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 UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
Yes
EUDAMED
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
Irrigation sleeve CO-MICS 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 | 76300039MD0105124V9 | 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 (2)
- EUDAMED 53ee551e-eb9c-4ede-9bc5-2fbcc7cca174 61 fields · synced Jun 19, 2026
- FDA UDI 3cbccdf5-2401-4571-8aab-eadcbbe1c828 34 fields · synced May 30, 2026