Taiwan FDA registration 1fb7e6957e1208e16589f10d456cad13

"Sibaite" Manual Orthopedic Surgical Device (Inverted Bacteria)

TW: "司佰特" 手動式骨科手術器械(未滅菌)

Taiwan·Risk Class 1·SPINEART SA;; ALPES CN SAS·Registered May 02, 2024 – May 02, 2029Active

Registration details

Analysis ID: 1fb7e6957e1208e16589f10d456cad13
Customs Code: DHA09402346100

Company information

Manufacturer: SPINEART SA;; ALPES CN SAS
Manufacturer Country: France;;Switzerland
Authorized Representative: JOINSMART BIOMEDICAL COMPANY LIMITED

Product details

Intended Use: It is limited to the first level of identification scope of manual orthopedic surgical instruments (N.4540) in the management measures for the classification and grading of medical devices.
Product Type (Level 1): N Orthopedics
Product Type (Level 2): N.4540 手動式骨科手術器械
Import Information: Input;; QMS/QSD

Dates and status

Registration Date: May 02, 2024
Expiry Date: May 02, 2029

About this record

Access comprehensive regulatory information for "Sibaite" Manual Orthopedic Surgical Device (Inverted Bacteria) in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 1 medical device is registered under number 1fb7e6957e1208e16589f10d456cad13 and manufactured by SPINEART SA;; ALPES CN SAS. The authorized representative in Taiwan is JOINSMART BIOMEDICAL COMPANY LIMITED.

This page provides complete technical specifications, regulatory compliance details. Pure Global AI offers free access to 89,000+ Taiwan medical device registrations, helping global MedTech companies navigate Taiwan FDA regulations, identify competitors, and discover partnership opportunities efficiently.