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EVA, combined machine
FDA UDIClass II (US FDA UDI)
by D.O.R.C. Dutch Ophthalmic Research Center (International) B.V.
Identity
- Trade Name
- EVA, combined machine FDA UDI
- Generic Name
- Phacoemulsification/vitrectomy system FDA UDI
- Model / Reference
- 8000.COM01 FDA UDI
Identifiers
- Catalog Number
- 8000.COM01 FDA UDI
- Primary DI / UDI-DI
- 08717872029672 FDA UDI
- 510(k) Number
- K142877 FDA UDI
- FDA Product Code
- HQC FDA UDIHQE FDA UDI
- GMDN Term
- Phacoemulsification/vitrectomy system FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 886.4670 FDA UDI886.4150 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
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
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Phacoemulsification/vitrectomy system
EVA, combined machine by D.O.R.C. Dutch Ophthalmic Research Center (International) B.V. — Class II — FDA UDI — listed in FDA GUDID
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Cleared under the same submission
K142877 also covers:
- 2.4 mm Disposable phaco set with 45° straight flared needle — D.O.R.C. Dutch Ophthalmic Research Center (International) B.V.
- 2.5 mm Straight phaco needle (limited reusable 20x) — D.O.R.C. Dutch Ophthalmic Research Center (International) B.V.
- Disposable frosted scleral depressor — D.O.R.C. Dutch Ophthalmic Research Center (International) B.V.
- EVA Custom Vitrectomy Pack VGPC 23G — D.O.R.C. Dutch Ophthalmic Research Center (International) B.V.
- EVA, anterior machine — D.O.R.C. Dutch Ophthalmic Research Center (International) B.V.
- EVA, combined machine including Laser (DORC connector) — D.O.R.C. Dutch Ophthalmic Research Center (International) B.V.
- EVA, combined machine including Laser (SMA connector) — D.O.R.C. Dutch Ophthalmic Research Center (International) B.V.
- I/A Handpiece with curved tip. — D.O.R.C. Dutch Ophthalmic Research Center (International) B.V.
- MICS 1.8 mm Triple step angled flared phaco needle. (limited reusable 20x) — D.O.R.C. Dutch Ophthalmic Research Center (International) B.V.
- Safety filter for Leica Microscopes, Manual — D.O.R.C. Dutch Ophthalmic Research Center (International) B.V.
- Safety filter for Leica Microscopes, Passive — D.O.R.C. Dutch Ophthalmic Research Center (International) B.V.
- Safety filter for Zeis/Moeller-Wedel Microscopes, Manual — D.O.R.C. Dutch Ophthalmic Research Center (International) B.V.
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
Sources (1)
- FDA UDI 86bef96b-5535-4192-aa79-b5835e22f907 34 fields · synced May 30, 2026