EVA NEXUSTM Custom Phaco Pack 1.8mm 45 (Angled)
FDA UDIEUDAMEDClass II (US FDA UDI)
by D.O.R.C. Dutch Ophthalmic Research Center (International) B.V.
Identity
- Trade Name
- EVA NEXUS Custom Phaco Pack 1.8mm 45 (Angled) EUDAMEDEVA NEXUSTM Custom Phaco Pack 1.8mm 45 (Angled) FDA UDI
- Generic Name
- Ophthalmic surgical procedure kit, non-medicated, single-use FDA UDI
- Device Name
- EVA NEXUS Custom Phaco Pack 1.8mm 45 (Angled) EUDAMED
- Model / Reference
- 9545.18AF1 EUDAMEDFDA UDI
Identifiers
- Primary DI / UDI-DI
- 08717872034348 EUDAMEDFDA UDI
- Basic UDI-DI
- B-08717872034348 EUDAMED
- 510(k) Number
- K213467 FDA UDI
- FDA Product Code
- HQC FDA UDIHQE FDA UDI
- EMDN Code
- Z1212020785 PHACO-VITRECTOMY INSTRUMENTS - CONSUMABLES EUDAMED
- GMDN Term
- Ophthalmic surgical procedure kit, non-medicated, single-use FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 886.4670 FDA UDI886.4150 FDA UDI
- Market of Registration
- Netherlands EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
Single Use
Yes
Implantable
No
Reusable
No
Contains Latex
No
Reprocessed
No
CMR Substance
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
Prescription Use
Yes
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
No
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
Yes
Manufacturing Date
No
Category: Ophthalmic surgical procedure kit, non-medicated, single-use
EVA NEXUSTM Custom Phaco Pack 1.8mm 45 (Angled) by D.O.R.C. Dutch Ophthalmic Research Center (International) B.V. — Class II — MDD, FDA UDI — listed in FDA…
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Cleared under the same submission
K213467 also covers:
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- 25G Two Dimensional Cutter – 20k CPM — D.O.R.C. Dutch Ophthalmic Research Center (International) B.V.
- 25G Two Dimensional Cutter – 20k CPM — D.O.R.C. Dutch Ophthalmic Research Center (International) B.V.
- 27G Two Dimensional Cutter – 20k CPM — D.O.R.C. Dutch Ophthalmic Research Center (International) B.V.
- 27G Two Dimensional Cutter – 20k CPM — D.O.R.C. Dutch Ophthalmic Research Center (International) B.V.
- 926823G Two Dimensional Cutter – 20k CPM — D.O.R.C. Dutch Ophthalmic Research Center (International) B.V.
- Directional Laser Probe with Alcon / Lumenis connector.(20 gauge / 0.9 mm) — D.O.R.C. Dutch Ophthalmic Research Center (International) B.V.
- Directional Laser Probe with Alcon / Lumenis connector.(23 gauge / 0.6 mm) — D.O.R.C. Dutch Ophthalmic Research Center (International) B.V.
- Directional Laser Probe with Alcon / Lumenis connector.(25 gauge / 0.5 mm) — D.O.R.C. Dutch Ophthalmic Research Center (International) B.V.
- Directional Laser Probe with Alcon / Lumenis connector.(27 gauge / 0.4 mm) — D.O.R.C. Dutch Ophthalmic Research Center (International) B.V.
- Directional Laser Probe with DORC connector.(20 gauge / 0.9 mm) — D.O.R.C. Dutch Ophthalmic Research Center (International) B.V.
Authorization Coverage (2 countries)
Regulatory Authorizations
MDD
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDD | — | Class II | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
Sources (2)
- FDA UDI 95f0e1ff-aac4-4b58-9b68-5a01812ee3ca 33 fields · synced Oct 9, 2026
- EUDAMED 76e4841d-fd08-4362-8956-4dc709012593 61 fields · synced Oct 9, 2026