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Singapore HSA registration DE0506338

Spiggle & Theis Stapes Prosthesis (Platinum/PTFE)

Singapore flagSingapore·CLASS C·Spiggle & Theis Medizintechnik GmbH·Registered November 01, 2021
Device classification
Device Class
CLASS C
Medical Speciality Area
Ear, Nose & Throat
Registration information
Registration Number
DE0506338
Registration Date
November 01, 2021
Retention Due Date
October 31, 2025
Product description
Reconstruction of the sound conduction chain between middle ear and inner ear through replacement of the stapes. Defective/destroyed stapes (tympanoplastic type III).
Product Owner
Name
Spiggle & Theis Medizintechnik GmbH
Short Name
Spiggle & Theis Medizintechnik GmbH
Address
Burghof 14, 51491 Overath, GERMANY
Registrant
Name
SMITH & NEPHEW PTE. LIMITED
Address
29 MEDIA CIRCLE, ALICE@MEDIAPOLIS, #06-05, SINGAPORE 138565
Importer
Name
SMITH & NEPHEW ASIA PACIFIC PTE. LIMITED SMITH & NEPHEW PTE. LIMITED
Address
29 MEDIA CIRCLE, ALICE@MEDIAPOLIS, #06-05, SINGAPORE 138565 29 MEDIA CIRCLE, ALICE@MEDIAPOLIS, #06-05, SINGAPORE 138565
Model information
Model Name(s)
Platinum / PTFE Stapes Piston, 0.4 x 4.25 mm applied length, (total length 5.25 mm), 1 piece Platinum / PTFE Stapes Piston, 0.4 x 4.50 mm applied length, (total length 5.50mm), 1 piece Platinum / PTFE Stapes Piston, 0.4x4.75 mm applied length, (total length 5.75mm), 1 piece Platinum / PTFE Stapes Piston, 0.4x6.00 mm applied length, (total length 7.00 mm), shortenable, 1 piece Platinum / PTFE Stapes Piston, 0.4 x 9.00 mm applied length, (total length 10.00 mm), shortenable, 1 piece Platinum / PTFE Stapes Piston, 0.6x4.25 mm applied length, (total length 5.25 mm), 1 piece Platinum / PTFE Stapes Piston, 0.6mmx4.50 mm applied length, (total length 5.50 mm), 1 piece Platinum / PTFE Stapes Piston, 0.6x4.75 mm applied length, (total length 5.75 mm), 1 piece Platinum / PTFE Stapes Piston, 0.6x6.00 mm applied length, (total length 7.00mm), shortenable, 1 piece Platinum / PTFE Stapes Piston, 0.6mmx9.00 mm applied length, (total length10.00 mm), shortenable, 1 piece
Model Identifier(s)
10540425 10540450 10540475 10540600 10540900 10560425 10560450 10560475 10560600 10560900
About this record

Access comprehensive regulatory information for Spiggle & Theis Stapes Prosthesis (Platinum/PTFE) in the Singapore medical device market through Pure Global AI's free database. This CLASS C medical device is registered under HSA registration number DE0506338 and owned by Spiggle & Theis Medizintechnik GmbH. The device was registered on November 01, 2021.

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.

Free DatabasePowered by Pure Global AIHSA Official DataCLASS C