Identity
- Trade Name
- Tri-Port Sub-Tenon EUDAMED
- Device Name
- Ophthalmic Cannula EUDAMED
- Model / Reference
- 100-19 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00810090010748 EUDAMED
- Basic UDI-DI
- 081009001CANNULAVB EUDAMED
- EMDN Code
- Q021101 OCCULAR IRRIGATION AND ASPIRATION CANNULAS, SINGLE-USE 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: Ophthalmic irrigation/infusion/aspiration cannula, non-illuminating, single-use
Tri-Port Sub-Tenon by Eagle Labs, LLC — Class IIa — MDR — listed in EUDAMED — regulatory data on deviCERTS
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Also classified as Ophthalmic irrigation/infusion/aspiration cannula, non-illuminating, single-use.
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- SURGISTAR — Surgistar Inc. · Class I
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 | 081009001CANNULAVB | Class IIa | Active |
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Manufacturer
- Manufacturer
- Eagle Labs, LLC
- EUDAMED SRN
- US-MF-000011740
- Authorised Representative
- IDN (INSTITUT DIETETIQUE ET NUTRITION) FR-AR-000003050
Sources (1)
- EUDAMED 84ff1b27-4801-4dc9-9ec0-0d352f9d0a8d 61 fields · synced Jul 19, 2026