Singapore HSA registration DE0503175
Menicon Rose K2 Rigid Contact Lenses
Singapore·CLASS B·Menicon Limited·Registered May 31, 2019Device classification
- Device Class
- CLASS B
- Medical Speciality Area
- Ophthalmology
Registration information
- Registration Number
- DE0503175
- Registration Date
- May 31, 2019
- Change Notification Approval Date
- November 21, 2023
- Retention Due Date
- May 30, 2025
Product description
The Rose K2 lens is prescribed for the treatment of irregular corneal conditions.
Product Owner
- Name
- Menicon Limited
- Short Name
- Menicon Limited
- Address
- 1 Gatelodge Close, Round Spinney, NORTHAMPTON, NN3 8RJ, UNITED KINGDOM
Registrant
- Address
- 38 JALAN PEMIMPIN, M38, #06-06, SINGAPORE 577178
Importer
- Address
- 38 JALAN PEMIMPIN, M38, #06-06, SINGAPORE 577178
Model information
- Model Name(s)
- "Rose K2 NC Nipple Cone Menicon Z; Power: -45.00 to +25.00 (0.125 increments), Smaller aspheric back optic zone diameter that decreases as the base curve steepens: BOZD 2.80 to 8.00 Rose K2 Menicon Z; Power: -42.00 to +40.00 (0.125 increments) Rose K2 IC Irregular Cornea Menicon Z; Power: -40.00 to +40.00 (0.125 increments), Larger Overall Diameter: Overall Diameter 9.00 to 12.50 Rose K2 XL Extra Limbal Menicon Z; Power: -40.00 to +40.00 (0.125 increments), Larger Overall Diameter: Overall Diameter 13.00 to 16.60 Rose K2 Menicon Z; Base Curve: 5.10 to 7.60, Diameter: 8.50 to 9.20, Power: -23.00 to -2.00 (1D increments) Rose K2 IC Irregular Cornea Menicon Z; Base Curve: 6.40 to 8.60, Diameter: 11.40, Power: -16.00 to +1.00 (1D & 2D increments) Rose K2 NC Nipple Cone Menicon Z; Base Curve: 4.60 to 7.40, Diameter: 8.10 to 8.90, Power: -28.00 to -2.00 (1D & 2D increments) Rose K2 XL Extra Limbal Menicon Z; Base Curve: 6.00 to 8.00, Diameter: 14.60, Power: -18.00 to +1.00 (1D increments) Rose K XL Oblate Menicon Z; Power: -40.00 to +40.00, pack of 1 Rose K XL Oblate Menicon Z; Power: -2.00 to +3.00, pack of 1 Rose K2 IC Irregular Cornea Menicon Z; Power: -40.00 to +40.00, pack of 1 Rose K2 IC Irregular Cornea Menicon Z; Power: -16.00 to +1.00, pack of 1 Rose K2 Menicon Z; Power: -42.00 to +40.00, pack of 1 Rose K2 Menicon Z; Power: -23.00 to -2.00, pack of 1 Rose K2 NC Nipple Cone Menicon Z; Power: -45.00 to +25.00, pack of 1 Rose K2 NC Nipple Cone Menicon Z; Power: -28.00 to -2.00, pack of 1 Rose K2 XL Extra Limbal Menicon Z; Power: -40.00 to +40.00, pack of 1 Rose K2 XL Extra Limbal Menicon Z; Power: -18.00 to +1.00, pack of 1
- Model Identifier(s)
- MAN100112 MAN100293 MAN100299 MAN100314 MAN100454 MAN100455 MAN100457 MAN100608 Rose K XL Oblate Menicon Z Rose K XL Oblate Menicon Z, for trial Rose K2 IC Irregular Cornea Menicon Z Rose K2 IC Irregular Cornea Menicon Z, for trial Rose K2 Menicon Z Rose K2 Menicon Z, for trial Rose K2 NC Nipple Cone Menicon Z Rose K2 NC Nipple Cone Menicon Z, for trial Rose K2 XL Extra Limbal Menicon Z Rose K2 XL Extra Limbal Menicon Z, for trial
About this record
Access comprehensive regulatory information for Menicon Rose K2 Rigid Contact Lenses in the Singapore medical device market through Pure Global AI's free database. This CLASS B medical device is registered under HSA registration number DE0503175 and owned by Menicon Limited. The device was registered on May 31, 2019.
This page provides complete registration details including product owner information, registrant details, importer information, and regulatory compliance data from the official Singapore HSA medical device database. Pure Global AI offers free access to Singapore's complete medical device registry, helping global MedTech companies navigate HSA regulations efficiently.
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