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Singapore HSA registration DE0508133

Spiggle & Theis Middle Ear Drainage and Ventilation Tube (PTFE)

Singapore flagSingapore·CLASS C·Spiggle & Theis Medizintechnik GmbH·Registered May 26, 2023
Device classification
Device Class
CLASS C
Medical Speciality Area
Ear, Nose & Throat
Registration information
Registration Number
DE0508133
Registration Date
May 26, 2023
Retention Due Date
May 25, 2025
Product description
Middle ear drainage and ventilation tube for implantation in the tympanic membrane by means of paracentesis (myringotomy). The product facilitates clearance of secretions from the middle ear (middle ear effusion) and ventilation/pressure equalization in the middle ear, relieving the auditive tube (Tube Eustachii). Indicated for middle ear effusion and chronic ventilation problems.
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)
PTFE Ventilation Tube, collar button, ID 1.0mm PTFE Ventilation Tube, collar button, with wire, ID 1.0 mm PTFE Ventilation Tube, Shepard, blue, ID 1.15 mm PTFE Ventilation Tube, Shepard, with wire, ID 1.15 mm PTFE Ventilation Tube, collar button, blue, ID 1.25 mm PTFE Ventilation Tube, collar button, with wire, ID 1.25 mm PTFE Ventilation Tube, collar button, blue, ID 1.5 mm PTFE Ventilation Tube, collar button, with wire, ID 1.5 mm PTFE Ventilation Tube, Shah, tab, ID 1.14 mm PTFE Ventilation Tube, Shah, ID 1.14 mm PTFE Ventilation Tube, Bevel-Bobbin, blue, ID 1.1 mm PTFE Ventilation Tube, Reuter-Bobbin, blue, ID 1.14 mm
Model Identifier(s)
104100 104100F 104115 104115F 104125 104125F 104150 104150F 104200 104210 104311 104414
About this record

Access comprehensive regulatory information for Spiggle & Theis Middle Ear Drainage and Ventilation Tube (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 DE0508133 and owned by Spiggle & Theis Medizintechnik GmbH. The device was registered on May 26, 2023.

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