Taiwan FDA registration 6df1706a220cf81a5702e2901d5fdbbb

“BIOTRONIK” CanGaroo Envelope

TW: “百多力”生物基質封袋

Taiwan·Risk Class 2·MD·Aziyo Biologics, Inc.·Registered Nov 04, 2021 – Nov 04, 2026Active

Registration details

Analysis ID: 6df1706a220cf81a5702e2901d5fdbbb
License Form: Ministry of Health Medical Device Import No. 034786
Customs Code: DHA05603478603

Company information

Manufacturer: Aziyo Biologics, Inc.
Manufacturer Country: United States
Authorized Representative: BIOTRONIK TAIWAN LIMITED

Product details

Intended Use: This product is used to immobilize cardiac implantable electronic devices (CIEDs) or implantable neurostimulators to create a stable environment when implants are implanted in the body. Devices that may be used with this product include pulse generators for heart rhythm apparatus, defibrillators or other cardiac implantable electronic devices. Implantable neurostimulator devices that may be used with this product include vagus nerve stimulators, spinal cord neuromodulators, deep brain stimulators, and neurostimulators.
Product Type (Level 1): I General and plastic surgical devices
Product Type (Level 2): I3300 Surgical mesh
Import Information: Imported from abroad

Dates and status

Registration Date: Nov 04, 2021
Expiry Date: Nov 04, 2026

About this record

Access comprehensive regulatory information for “BIOTRONIK” CanGaroo Envelope in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 2 medical device is registered under number 6df1706a220cf81a5702e2901d5fdbbb and manufactured by Aziyo Biologics, Inc.. The authorized representative in Taiwan is BIOTRONIK TAIWAN LIMITED.

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