Sdi Limited

Active in EUDAMED

Australiafrom SRN EUDAMED SRN AU-MF-000024633

Devices: 83
Registrations: EUDAMED
FDA recalls: 11 ongoing

Catalogue83

Newest first, page 2 of 2

Luna Flow 1 Syr A4 Ref 8566105

Class IIa EUDAMED Active
Luna 2 1 Syr C2 Ref 8452010

Class IIa EUDAMED Active
Luna Flow Bulk Kt A2 Ref 8566131

Class IIa EUDAMED Active
Aura Easyflow 1 Syr AE4 Ref 8566013

Class IIa EUDAMED Active
Luna 2 1 Syr B2 Ref 8452007

Class IIa EUDAMED Active
Luna Flow 1 Syr D2 Ref 8566112

Class IIa EUDAMED Active
Luna Flow 1 Syr OA3 Ref 8566116

Class IIa EUDAMED Active
Luna 2 20 Comp A4 Ref 8452055

Class IIa EUDAMED Active
Luna 2 20 Comp B Ref 8452070

Class IIa EUDAMED Active
Luna 2 1 Syr B1 Ref 8452006

Class IIa EUDAMED Active
Luna 2 20 Comp D3 Ref 8452063

Class IIa EUDAMED Active
Aura Easyflow 1 Syr AE2 Ref 8566011

Class IIa EUDAMED Active
Luna 2 20 Comp C2 Ref 8452060

Class IIa EUDAMED Active
Luna 2 1 Syr OA3 Ref 8452016

Class IIa EUDAMED Active
Aura Easyflow 1 Syr AE3 Ref 8566012

Class IIa EUDAMED Active
Luna 2 1 Syr OA2 Ref 8452015

Class IIa EUDAMED Active
Luna 2 20 Comp 2XB Ref 8452072

Class IIa EUDAMED Active
Luna 2 20 Comp OA3.5 Ref 8452067

Class IIa EUDAMED Active
Luna Flow 1 Syr A3 Ref 8566103

Class IIa EUDAMED Active
Luna Flow Lv 1 Syr 2XB Ref 8566222

Class IIa EUDAMED Active
Luna Flow Lv 1 Syr OA2 Ref 8566215

Class IIa EUDAMED Active
Stela Capsules Sample Ref 9900195

Class IIa EUDAMED Active
Stela Capsule System Ref K222583

Class II FDA 510(k) Active
Riva Cem Automix Ref K214118

Class II FDA 510(k) Active
Zipbond Ref K191656

Class II FDA 510(k) Active
Riva Star Ref K172047

Class II FDA 510(k) Active
Stela Automix System Ref K222581

Class II FDA 510(k) Active
Aura Ref K102984

Class II FDA 510(k) Active
Stela Automix 1 Syr Refill Ref 8640001

Class IIa EUDAMEDFDA UDI Active
Stela Primer Refill 5ml Bt Ref 8640006

Class IIa EUDAMEDFDA UDI Active
Stela Automix Intro Kit Ref 8640002

Class IIa EUDAMEDFDA UDI Active
Stela Capsules Intro Kt Ref 8640004

Class IIa EUDAMEDFDA UDI Active
Stela Capsules Refill 50 Cap Ref 8640003

Class IIa EUDAMEDFDA UDI Active

Showing 51-83 of 83

Company details

EUDAMED SRN: AU-MF-000024633
DUNS number: 753221852
EUDAMED status: Active
EUDAMED registered name: SDI Limited
EUDAMED abbreviated name: SDI
Registered address: 3-15, Brunsdon, 3153, Bayswater, Australia
Website: www.sdi.com.au
Email: [email protected]
Phone: +6187277111
PRRC contact: Lyn Chau(public in EUDAMED)

FDA recalls1

Recalls are matched to the firm by name.

FDA recall records list 1 recall initiated by SDI LIMITED, initiated on 2026-07-20. By recorded status: 1 ongoing. The reasons filed fall into these groups: electrical or power. A recall is often a precaution started by the manufacturer, and a count of records is not a verdict on a company.

Generated automatically from FDA recall records, as a summary of the records listed below. It describes what the records state and is not an assessment of this manufacturer.

2026
- 20 Jul 2026 Z-2954-2026 Class II Ongoing Potential for electrical discharge from unit when unplugged.

What Sdi Limited makes

SDI Limited manufactures dental composite resins and related dental products, including the Stela Capsule System, Riva Cem Automix, Zipbond, Riva Star, AURA, and various refill kits and primers.

The company's portfolio includes Class II and Class IIa devices listed in eudamed and fda_510k registries, and is based in Australia.

AI-generated from registry data, 26 Oct 2026. Not verified by deviCERTS or the manufacturer.

Catalogue83

Luna Flow 1 Syr A4 Ref 8566105

Luna 2 1 Syr C2 Ref 8452010

Luna Flow Bulk Kt A2 Ref 8566131

Aura Easyflow 1 Syr AE4 Ref 8566013

Luna 2 1 Syr B2 Ref 8452007

Luna Flow 1 Syr D2 Ref 8566112

Luna Flow 1 Syr OA3 Ref 8566116

Luna 2 20 Comp A4 Ref 8452055

Luna 2 20 Comp B Ref 8452070

Luna 2 1 Syr B1 Ref 8452006

Luna 2 20 Comp D3 Ref 8452063

Aura Easyflow 1 Syr AE2 Ref 8566011

Luna 2 20 Comp C2 Ref 8452060

Luna 2 1 Syr OA3 Ref 8452016

Aura Easyflow 1 Syr AE3 Ref 8566012

Luna 2 1 Syr OA2 Ref 8452015

Luna 2 20 Comp 2XB Ref 8452072

Luna 2 20 Comp OA3.5 Ref 8452067

Luna Flow 1 Syr A3 Ref 8566103

Luna Flow Lv 1 Syr 2XB Ref 8566222

Luna Flow Lv 1 Syr OA2 Ref 8566215

Stela Capsules Sample Ref 9900195

Stela Capsule System Ref K222583

Riva Cem Automix Ref K214118

Zipbond Ref K191656

Riva Star Ref K172047

Stela Automix System Ref K222581

Aura Ref K102984

Stela Automix 1 Syr Refill Ref 8640001

Stela Primer Refill 5ml Bt Ref 8640006

Stela Automix Intro Kit Ref 8640002

Stela Capsules Intro Kt Ref 8640004

Stela Capsules Refill 50 Cap Ref 8640003

Company details

FDA recalls1

Related companies

Authorised representatives

What Sdi Limited makes