Tek-Lens II
by Tekia, Inc. United States EUDAMED
Ref 618, 872S, 617, 872Y, 820, 820Y, 811Y
EMDN P030102090202
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDD | NumberB-++M519TEK01256 | Date2 Jan 2025 | StatusActive |
Coverage
- Expiring (legacy directive)
- Not covered
European Union — CE/MDD Expiring (legacy directive)
Specification
- Device Name
- Hydrophilic Acrylic Intraocular lens
- Model / Reference
- 618, 872S, 617, 872Y, 820, 820Y, 811Y
- Primary DI / UDI-DI
- ++M519TEK01256, ++M519TEK0085F, ++M519TEK01052, ++M519TEK0075D, ++M519TEK00457, ++M519TEK00559, ++M519TEK00355
- Basic UDI-DI
- B-++M519TEK01256, B-++M519TEK0085F, B-++M519TEK01052, B-++M519TEK0075D, B-++M519TEK00457, B-++M519TEK00559, B-++M519TEK00355
- EMDN Code
- P030102090202, P030101030102
- Device Class
- Class IIb
- Market of Registration
- ItalyGermany
Manufacturer details
- EUDAMED SRN
- US-MF-000020955
- Authorised representative
- CALICEOS FR-AR-000009387
Other devices from Tekia, Inc.
Properties & raw data
Show properties, registry sources and raw records
Other properties (9)
- Reusable: No
- Contains Latex: No
- Reprocessed: No
- Human-derived: No
- Human Tissues: No
- Animal Tissues: No
- Administering Medicine: No
- Measuring Function: No
- Incorporates Medicinal Product: No
Sources (7)
- EUDAMED e335837b-aedb-4aa1-82dc-d55603bc25b1
- EUDAMED ++M519TEK0085F|B-++M519TEK0085F
- EUDAMED ++M519TEK01052|B-++M519TEK01052
- EUDAMED ++M519TEK0075D|B-++M519TEK0075D
- EUDAMED ++M519TEK00457|B-++M519TEK00457
- EUDAMED ++M519TEK00559|B-++M519TEK00559
- EUDAMED ++M519TEK00355|B-++M519TEK00355