Tutopatch™ ECM 8 cm x 14 cm

FDA UDI

Class II (US FDA UDI)

by Tutogen Medical GmbH

Identity

Trade Name: Tutopatch™ ECM 8 cm x 14 cm FDA UDI
Generic Name: Extra-gynaecological surgical mesh, collagen, bioabsorbable, non-antimicrobial FDA UDI
Device Name: Bovine Pericardium 8 x 14 cm FDA UDI
Model / Reference: BPE814 FDA UDI
Description: Bovine Pericardium 8 x 14 cm FDA UDI

Identifiers

Catalog Number: BPE814 FDA UDI
Primary DI / UDI-DI: 14041543313496 FDA UDI
510(k) Number: K081538 FDA UDI
K991296 FDA UDI
FDA Product Code: PAJ FDA UDI
FTM FDA UDI
DXZ FDA UDI
OXH FDA UDI
GMDN Term: Extra-gynaecological surgical mesh, collagen, bioabsorbable, non-antimicrobial FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 878.3300 FDA UDI
870.3470 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

Yes

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

FDA UDI

Category: Extra-gynaecological surgical mesh, collagen, bioabsorbable, non-antimicrobial

Tutopatch™ ECM 8 cm x 14 cm by Tutogen Medical GmbH — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Cleared under the same submission

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

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Manufacturer

Manufacturer: Tutogen Medical GmbH

Sources (1)

FDA UDI de50b649-4e39-4b96-811a-a9e5b481627b 36 fields · synced Jun 8, 2026

Tutopatch™ ECM 8 cm x 14 cm

Identity

Identifiers

Classification

Clinical & Handling

Similar devices

Cleared under the same submission

Authorization Coverage (1 country)

Regulatory Authorizations

Manufacturer

Sources (1)