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EVA NEXUS™ cartridge with 0, 5 L collection bag
FDA UDIEUDAMEDClass II (US FDA UDI)
Ref 9100.CAR01
by D.O.R.C. Dutch Ophthalmic Research Center (International) B.V.
Identity
- Trade Name
- EVA NEXUS cartridge with 0,5 L collection bag EUDAMEDEVA NEXUS™ cartridge with 0,5 L collection bag FDA UDI
- Generic Name
- Ophthalmic surgical procedure kit, non-medicated, single-use FDA UDI
- Device Name
- EVA NEXUS cartridge with 0,5 L collection bag EUDAMED
- Model / Reference
- 9100.CAR01 EUDAMEDFDA UDI
Identifiers
- Primary DI / UDI-DI
- 08717872032788 EUDAMEDFDA UDI
- Basic UDI-DI
- B-08717872032788 EUDAMED
- 510(k) Number
- K213467 FDA UDI
- FDA Product Code
- HQC FDA UDIHQE FDA UDIHQF FDA UDI
- EMDN Code
- Q021113 OPHTHALMIC SURGERY INSTRUMENT KITS, SINGLE-USE 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 UDI886.4390 FDA UDI
- Market of Registration
- Netherlands EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
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
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Ophthalmic surgical procedure kit, non-medicated, single-use
EVA NEXUS™ cartridge with 0, 5 L collection bag 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:
- 1cc syringe holder for micro-injection — D.O.R.C. Dutch Ophthalmic Research Center (International) B.V.
- 23G 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.
- 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
European Union Unknown
MDD
United States Pending data
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 888f9717-1360-4ff4-8327-5490b4416827 33 fields · synced Oct 9, 2026
- EUDAMED fafe46c9-139c-4a2e-bc23-2ad9c27a32e9 61 fields · synced Oct 9, 2026