MOLTENO OPHTHALMIC LIMITED
New Zealand NZ-MF-000009956 Last updated 27 May 2026
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- Devices
- 15
- Registries
- EUDAMEDGUDID
- FDA recalls
- 0
Catalogue
Molteno S1 Ref S1
Molteno M-Sphere MS20 Ref MS20
Molteno L2 Ref L2
Molteno R2 Ref R2
Molteno DL2 Ref DL2
Molteno P1 Ref P1
Molteno DR2 Ref DR2
Molteno M-Sphere MS18 Ref MS18
Molteno M-Sphere MS16 Ref MS16
Molteno D1 Ref D1
Molteno3 GS-175 Ref GS-175
Molteno MoaBone MS08 Ref MS08
Molteno M-Sphere MS22 Ref MS22
Molteno3 GL-230 Ref GL-230
Molteno3 Ref SS-185
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Authorised representatives
What MOLTENO OPHTHALMIC LIMITED makes
Molteno Ophthalmic Limited manufactures the Molteno3, a glaucoma drainage implant designed to reduce intraocular pressure in patients with advanced glaucoma. This device is intended for surgical implantation to provide long-term management of fluid drainage within the eye.
The Molteno3 is classified as a Class IIb medical device under EU regulations and is registered in the EUDAMED database. The company is based in New Zealand.
Frequently asked questions
What types of medical devices does Molteno Ophthalmic Limited manufacture?
Molteno Ophthalmic Limited specializes in manufacturing glaucoma drainage implants. Their primary product, the Molteno3, is designed to surgically reduce intraocular pressure in patients with advanced glaucoma by providing long-term drainage of fluid within the eye.
Where is Molteno Ophthalmic Limited based?
Molteno Ophthalmic Limited is headquartered in New Zealand. The company’s location influences its regulatory compliance, particularly for devices intended for markets like the European Union.
How are Molteno Ophthalmic Limited’s devices classified under EU regulations?
Molteno Ophthalmic Limited’s devices, such as the Molteno3, fall under Class IIb classification in the EU. This classification applies to devices that pose a moderate risk to patients and require additional scrutiny, such as conformity assessments and post-market surveillance, to ensure safety and performance.
Are Molteno Ophthalmic Limited’s devices listed in any regulatory databases?
Yes, Molteno Ophthalmic Limited’s devices are registered in the EUDAMED database. This platform is the official EU portal for medical device information, including device identification, manufacturers, and regulatory status, ensuring transparency for healthcare professionals and regulators.
Information
- Country
- New Zealand
- Address
- 152, Frederick Street, Dunedin, New Zealand
- Website
- www.glaucoma-molteno.com/
- [email protected]
- Phone
- +64 34792744
- PRRC contact
- Emma Brew-MacDonald
- EUDAMED SRN
- NZ-MF-000009956
- DUNS number
- 760385075