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Singapore HSA registration DE0508532

Spiggle & Theis Ventilation Tubes (Silicone)

Singapore flagSingapore·CLASS C·Spiggle & Theis Medizintechnik GmbH·Registered October 03, 2023
Device classification
Device Class
CLASS C
Medical Speciality Area
Ear, Nose & Throat
Registration information
Registration Number
DE0508532
Registration Date
October 03, 2023
Retention Due Date
October 02, 2025
Product description
Middle ear drainage and ventilation tube (“vent 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 equalisation in the middle ear, relieving the auditive tube (Tuba Eustachii). Indications: • Middle ear effusion (serious otitis media, swimmer’s ear, glue ear). • 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)
Ventilation tubes, silicone, Donaldson, ID 1.1 mm, sterile, 10 pieces/box Ventilation tubes, silicone, Donaldson, tab, ID 1.1 mm, sterile, 10 pieces/box Ventilation tubes, silicone, T-Tube, length 5 mm, ID 1.14 mm, sterile, 10 pieces/box Ventilation tubes, silicone, Grommet-T, ID 1.27 mm, sterile, 10 pieces/box Ventilation tubes, silicone, Parapella I, tab, ID 1.1 mm, sterile, 10 pieces/box Ventilation tubes, silicone, Parapella II, tab, ID 1.5 mm, sterile, 10 pieces/box
Model Identifier(s)
103000 103010 103150 103200 103300 103310
About this record

Access comprehensive regulatory information for Spiggle & Theis Ventilation Tubes (Silicone) in the Singapore medical device market through Pure Global AI's free database. This CLASS C medical device is registered under HSA registration number DE0508532 and owned by Spiggle & Theis Medizintechnik GmbH. The device was registered on October 03, 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