MedSkin Solutions Dr. Suwelack AG

FDA Device Registration & Listing · BILLERBECK North Rhine-Westphalia, DE · Registration 3002636527

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3002636527
FEI Number
3002636527
Entity Name
MedSkin Solutions Dr. Suwelack AG
City/State/Country
BILLERBECK North Rhine-Westphalia, DE
Establishment Address
JOSEF-SUWELACK-STRASSE 2, BILLERBECK North Rhine-Westphalia 48727, DE
Establishment Type(s)
Manufacture Medical Device
Owner / Operator
MedSkin Solutions Dr. Suwelack AG (Owner Number: 9083271)
Owner / Operator Contact Address
JOSEF-SUWELACK-STRASSE 2, --, BILLERBECK, DE-NW 48727, DE
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
K060456
PMA Number
N/A

All Registered Proprietary Names

MatriDerm pluS+ Bi-Layer MatriDerm Puracol Plus Ag Collagen Wound Dressing Puracol-Puracol Plus

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
KGN Wound Dressing With Animal-Derived Material(S) Unknown Class U N/A 2026-04-22
KGN Wound Dressing With Animal-Derived Material(S) Unknown Class U N/A 2021-08-30
MQV Filler, Bone Void, Calcium Compound Orthopedic Class 2 888.3045 2023-12-18
FRO Dressing, Wound, Drug Unknown Class U N/A 2008-12-29
KGN Wound Dressing With Animal-Derived Material(S) Unknown Class U N/A 2010-03-01
KGN Wound Dressing With Animal-Derived Material(S) Unknown Class U N/A 2006-07-26

Official Correspondent

Claudia Doberenz

US Agent Details

Scott Goodridge Business: SUWELACK MATRIX SYSTEMS, INC. Email: scott.goodridge@medskin-suwelack.com Phone: (817) 3374400

Related Public Records

Same Entity

MedSkin Solutions Dr. Suwelack AG
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K112888 Kensey Nash Corporation MESO WOUND MATRIX 2012-02-10
K040211 Collagen Matrix, Inc. MODIFICATION TO: COLLAGEN TOPICAL WOUND DRESSING 2004-02-27
K180121 Cellumed Co., Ltd. Rafugen DBM 2018-04-11
K062691 Takiron Co., Ltd. COMPORUS 2008-04-15
K023703 Berkeley Advanced Biomaterials, Inc. BI-OSTETIC 2003-01-30

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0003-06 B. Braun Medical, Inc. U
D-Stat Dry Hemostatic Bandage. The product is an adhesive bandage.
Z-0038-2025 3M Company Health Care Business 3m Center U
3M Tegaderm CHG, Chlorhexidine Gluconate I.V. Securement Dressing, REF 1658R

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3002636527. Last updated year: 2026. Please use registration number 3002636527 when referencing this establishment in official correspondence.
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