Polynovo Biomaterials Pty Limited
Company-provided description, not an official-source fact. Certifications, capacities, years and market positions stated in it are the company's own claims until a record below confirms them.
브라질 보건 규제 기관인 ANVISA는 2029년 9월 22일까지 유효한 의료 기기(MDSAP 감사 프로그램)에 대해 이 공장에 대해 유효한 우수 제조 관리 기준 인증서를 보유하고 있습니다. 인증서는 공장 자체를 검사한 후에 발급되므로 외국 규제 기관에서 이 사이트를 명명합니다. 여기서 생산된 제품은 브라질 시장에서 허용됩니다. 프로세스 번호 25351154542202517.
- Type
- manufacturer (our classification of the record, not a statement by the company)
- Role
- Manufacturer (official record)
- Location
- Australia
- Categories
- 의료 및 건강 관리 용품
- Markets
- 오스트레일리아, 브라질
Listed in a source registry
What is established and what is not
No researcher review has been written for this company yet. 5 official records from 4 official sources are on file. 2 other entries are not official records: our own technical checks and searches, open directory listings, our inferences or the company's own statements. Everything is listed below with its evidence type: each entry confirms only what it literally says; none of them is a review. The manufacturing role above rests on the official records listed below, and only as far as each literally goes: a facility registration or licence is not an observation of current production. Nothing here confirms ownership or trading status beyond what each record literally says.
Facts on file, each with its evidence type
- No match found on the sanctions lists we checked (record type: sanctions-clear) [our own observation, not an official record; name search, no matching candidate] We searched the public sanctions datasets and found no matching candidate. A name search is not full compliance screening. checked 2026-09-02. OpenSanctions
- No match found in the debarment registers we checked (record type: debarment-clear) [our own observation, not an official record; name search, no matching candidate] We searched the public debarment datasets and found no matching candidate. Absence from these lists is a search result, not a certificate. checked 2026-09-02. OpenSanctions
- product-authorised-for-sale-holder (record type: product-authorised-for-sale-holder) [official record; status green] Applicant to the US FDA for 5 medical devices: NovoSorb BTM (K251567, 2025-06-20), NovoSorb® MTX (K242149, 2025-03-05), NovoSorb Matrix (K221686, 2022-09-15) +2. The applicant answers for the notification; the record does not say who makes the device. A national regulator lists this company as the holder of the registration of products it has authorised for sale in that country. The holder answers for the product on that market; the record does not say the holder makes it. effective since 2026-10-05. FDA premarket notifications 510(k) and De Novo (openFDA, U.S. Food and Drug Administration)
- Registry ID checks out with the state register (record type: registry-id-verified) [official record; status green] Helps confirm the company on this page is the same legal entity as in the register. checked 2026-09-23. Australian Securities and Investments Commission (ASIC) company register
- On the company register (record type: registered-since) [official record; status green] Shows how long the company has been on the state register, which is hard to fake and easy to check. checked 2026-09-23. Australian Securities and Investments Commission (ASIC) company register
- manufacturing-practice-certified (record type: manufacturing-practice-certified) [official record; status green] A regulator of health products inspected this site and certified how it manufactures the product class named, for example medical devices or cosmetics. It is about manufacturing practice at the site, not a medicines licence. checked 2026-10-03. ANVISA (Brazilian Health Regulatory Agency), public register of Good Manufacturing Practice certificates (CBPF)
- Registered as a manufacturer (record type: registered-manufacturer) [official record; status green] Its own declared activity in the register covers making these goods. checked 2026-10-03. Agencia Estatal de Medicamentos y Tecnologias en Salud (AGEMED, Bolivia), listado oficial de registros sanitarios aprobados
Import rules for these goods
- Medical devices sold in the EU must carry CE marking under the Medical Device Regulation (EU) 2017/745, with a conformity assessment matched to the device risk class. European Commission (MDR)
- For the US market, the maker must have an FDA device establishment registration and product listing; most instruments also need 510(k) premarket clearance. US FDA (devices)