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Sterile Ophthalmic Surgical Procedure Pack
EUDAMEDClass IIa (EU MDR)
Ref PA22.D01
by VitreQ B.V.
Identity
- Device Name
- Sterile Ophthalmic Surgical Procedure Pack EUDAMED
- Model / Reference
- PA22.D01 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08719214224004 EUDAMED
- Basic UDI-DI
- 871921422995GS EUDAMED
- EMDN Code
- Z1212020785 PHACO-VITRECTOMY INSTRUMENTS - CONSUMABLES EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Netherlands EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
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
Category: Phacoemulsification system handpiece tip, single-use
Sterile Ophthalmic Surgical Procedure Pack by Vitreq B.V. — Class IIa — MDR — listed in EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Phacoemulsification system handpiece tip, single-use.
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- UNITY — Alcon Laboratories, Inc. · Class IIb
- 2.8 mm Disposable phaco set with 45° angled flared needle Note: Incision size 2. — D.O.R.C. Dutch Ophthalmic Research Center (International) B.V. · Class II
- Constellation — Alcon Laboratories, Inc. · Class IIb
- AMO PHACO NEEDLE — Johnson & Johnson Surgical Vision, Inc. · Class II
- UNITY — Alcon Laboratories, Inc. · Class IIa
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 871921422995GS | Class IIa | Active |
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Manufacturer
- Manufacturer
- VitreQ B.V.
- EUDAMED SRN
- NL-MF-000000424
Sources (1)
- EUDAMED 1a537239-d0fd-4ef5-9e1a-68cb78a5f233 61 fields · synced Jul 21, 2026