Taiwan FDA registration d08a1170f0f4b5f80b791b824fefcf71

"European" surgical instruments (unsterilized)

TW: 〝歐式〞手術用器械 (未滅菌)

Taiwan·Risk Class 1·ORTHOFIX S.R.L.·Registered Nov 22, 2005 – Nov 22, 2010Cancelled

Registration details

Analysis ID: d08a1170f0f4b5f80b791b824fefcf71
Customs Code: DHA04400206403

Company information

Manufacturer: ORTHOFIX S.R.L.
Manufacturer Country: Italy
Authorized Representative: CHAWEI CO., LTD.

Product details

Intended Use: A manual orthopaedic surgical device is a hand-held device that can be cut in orthopedic surgery or can be combined with other equipment. Common types include fracture wrappers, sharp diamonds, crust frames, myelin extractors, rounds, soft screws, drills, hammers, metal wire cutters, repair drives, extractors, steel tools, forks, sewing needle holders, rammers, bending or shaping instruments, compression instruments, transmitters, groove positioners, probes, femoral stem punchers, groove pushers, hole extensions, bone cutters, scissors, mallets, bone slide wooden ring (U-needle) mallets, plug tighteners, bone plugs, round hammers, metal wire twisters, and rotors.
Product Type (Level 1): N Orthopedics
Product Type (Level 2): N.4540 手動式骨科手術器械
Import Information: import

Dates and status

Registration Date: Nov 22, 2005
Expiry Date: Nov 22, 2010
Cancellation Date: Nov 23, 2012

Cancellation information

Status: Logged out
Reason: 許可證已逾有效期

About this record

Access comprehensive regulatory information for "European" surgical instruments (unsterilized) in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 1 medical device is registered under number d08a1170f0f4b5f80b791b824fefcf71 and manufactured by ORTHOFIX S.R.L.. The authorized representative in Taiwan is CHAWEI CO., LTD..

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