manufactured · input

Medical-Grade Atelocollagen (Wound Care / Bone Regeneration / Device OEM)

Highly purified atelocollagen (telopeptide-removed type I collagen) produced at ISO 13485 / ISO 22442 certified facilities for use in: wound dressings, hemostatic sponges, guided tissue/bone regeneration membranes, artificial bone substitutes, and collagen-based aesthetic injectables. Unlike food-grade collagen, medical-grade requires endotoxin levels below 0.5 EU/ml (FDA standard). B2B supply to medical device OEMs. Primary global suppliers: Nitta Gelatin (Japan), Devro (UK), Collagen Matrix (US), and Victory Biotech (China, Shenguan subsidiary).

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Source countries

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Companies

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Goods affected

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Claims on record

Where it comes from

Source countries

Share of global supply, by country.

Who makes it

Supplier companies

7 companies produce medical-grade atelocollagen (wound care / bone regeneration / device oem).

Koken Co., Ltd.

HQ JP30% share

Self-described world leader in atelocollagen R&D since 1959; dominant in academic research and medical device OEM supply globally via AteloCell product line. Operates atelocollagen.com as a dedicated product portal. Almost invisible in English-language Western supply chain analysis despite likely being the largest single-company volume producer of purified atelocollagen globally. Sold primarily through Japanese distributors (Cosmo Bio USA for North American research).

Regenity Biosciences

HQ US18% share

Formerly Collagen Matrix Inc. OEM/private-label manufacturer of bovine-derived atelocollagen for medical device applications; holds 58+ FDA 510(k) clearances dating to 1997. Acquired European facility in Groningen, Netherlands for EU market access. Major OEM supplier for wound dressings, hemostatic sponges, and bone regeneration membranes.

Nitta Gelatin Inc.

HQ JP12% share

Major Japanese gelatin and collagen producer; produces beMatrix and Cellmatrix medical-grade biocompatibility collagen under ISO 13485. Filed FDA Device Master File -- unusual transparency for a B2B supplier. Serves cell therapy and medical device OEM markets. Hyogo prefecture manufacturing plants in addition to Osaka operations.

Shenguan Holdings (Group)(0829.HK)

HQ CN12% share

Dominant Chinese collagen casing manufacturer; 80% of China's domestic collagen casing market. Listed on Hong Kong Stock Exchange. Founded 1989 in Guangxi. Also manufactures pharmaceutical products, skin care products, health care products for pregnant women and toddlers, and bioactive collagen products from the same bovine collagen source as its sausage casings. The company that makes 80% of China's sausage casings also makes Chinese pharmaceutical-grade collagen and maternal health products — all from the same Guangxi slaughterhouse-sourced bovine corium.

Collagen Solutions (Evergen)

HQ GB8% share

UK-based medical-grade collagen supplier; explicitly sources bovine hides from Australian and New Zealand BSE-free herds (post-1996 UK BSE regulatory requirement). GMP, EDQM, ISO 13485, ISO 22442 certified. Approved OEM supplier for major medical device OEMs globally. Has rebranded as Evergen in some markets.

EnColl Corporation

HQ US3% share

Specialty atelocollagen producer founded 1994; proprietary Two-step Enzyme Treatment Process (TTP) producing 99% pure Type I collagen (Helicoll product line). Small-scale specialized operation. 40+ years R&D experience in collagen purification chemistry.

Van Hessen (SARIA)

HQ NL

Self-described 'leading global player in the harvesting, processing and distribution of natural casings, meat products and pharmaceutical products.' Part of SARIA's Food & Pharma division since 2017; SARIA is also parent of Devro (collagen casings) — making SARIA the parent of the world's largest natural casing company AND the world's largest collagen casing company simultaneously. Van Hessen operates gutrooms inside slaughterhouses globally, positioned 'close to the source.' Also extracts pharmaceutical raw materials (heparin, collagen) from the same intestines processed for casings. Recent acquisitions: full ownership of Westpol-Teeuwissen (Netherlands/Poland).