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Cannula Insertion System
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref 5600GENModel CANNULA, TROCAR, OPHTHALMIC
Identity
- Trade Name
- Cannula Insertion System EUDAMEDNA FDA UDI
- Generic Name
- Ophthalmic cannulation set, single-use FDA UDI
- Device Name
- Cannula Insertion System EUDAMEDCannula Insertion System, 25 Gauge, Sterile, Single Step, Generic, w/ Tubing Set FDA UDI
- Model / Reference
- CANNULA, TROCAR, OPHTHALMIC EUDAMED5600GEN EUDAMEDFDA UDI
- Description
- Cannula Insertion System, 25 Gauge, Sterile, Single Step, Generic, w/ Tubing Set FDA UDI
Identifiers
- Catalog Number
- 5600GEN FDA UDI
- Primary DI / UDI-DI
- 10812480011233 EUDAMED00812480011236 FDA UDI
- Basic UDI-DI
- 081248001CISAG EUDAMED
- Direct Marketing DI
- 10812480011233 EUDAMED
- FDA Product Code
- HMX FDA UDINGY FDA UDI
- EMDN Code
- Q021199 OPHTHALMIC SURGERY INSTRUMENTS, SINGLE-USE - OTHER EUDAMED
- GMDN Term
- Ophthalmic cannulation set, single-use FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass I FDA UDI
- Regulation Number
- 886.4350 FDA UDI
- Market of Registration
- Germany 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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Dimensions & Sizes
- Size
- Needle Gauge — 25 Gauge FDA UDI
Cannula Insertion System by Medical Instrument Development Laboratories, Inc. — Class IIa — MDR, FDA UDI — listed in EUDAMED, FDA GUDID
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 081248001CISAG | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- Medical Instrument Development Laboratories, Inc.
- EUDAMED SRN
- US-MF-000033104
- Authorised Representative
- Emergo Europe B.V. NL-AR-000000116
Sources (2)
- EUDAMED c48e41bc-3f91-4fdf-95ee-6220564daeba 61 fields · synced Jul 31, 2026
- FDA UDI 54bb0038-f4d3-4735-be1d-ee5a3c0bf7cc 36 fields · synced May 30, 2026