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Andover Healthcare Inc.

United States·US-MF-000035055

Last updated September 18, 2026

About

WELCOME TO OVIK HEALTH Advanced Clinical Products that advance your Care We’re your partners in problem solving. From advanced wound care to antimicrobial silver and Active Fluid Management®, our products and technologies are designed to take care further. Get to Know OVIK Health We are a team of innovators, advancing healthcare technologies to improve patient \[…\]

From the manufacturer's own website. Source

Information

Country
United States
Address
9, Fanaras Drive, Salisbury, MA, United States
LinkedIn
—
Facebook
—
Phone
+1 864 237 1520
PRRC Contact
Sherry Albritton
EUDAMED SRN
US-MF-000035055
FDA FEI Number
—
DUNS Number
088528245

Catalogue (129)

Page 3 of 3
DeviceModel / ReferenceRegistriesClassStatus
Ubc NL W/IND TN/PK 3"
FDA UDI
Class IActive
Coflex TAN 2"X5Yds
FDA UDI
Class IActive
CoFlex TLC LTE LY2 6" X 3.8 Yds
EUDAMEDFDA UDI
Class IActive
CoFlex TLC LY1 FOAM 4" X 3.8 Yds
EUDAMEDFDA UDI
Class IActive
CoFlex TLC LITE LY2 4" X 3.8 Yds
EUDAMEDFDA UDI
Class IActive
Coflex CPK, 3" x 5 Yds
FDA UDI
Class IActive
Ubc W/IND TN/PK 4"
FDA UDI
Class IActive
CoFlex TLC LS STD TAN/LB 4"
FDA UDI
Class IActive
Coflex TLC Tan, 4"
FDA UDI
Class IActive
Coflex NL TAN, 4" X 5 Yds
FDA UDI
Class IActive
CoFlex TLC Single Zinc UB830Z-01
EUDAMEDFDA UDI
Class IActive
CoFlex TLC LS 7900TLC-TN-INTL
EUDAMED
Class IActive
CoFlex TLC 7800TLC-TN-INTL
EUDAMED
Class IActive
AndoFlex Calamine Single ASP-UB840C-01
EUDAMED
Class IActive
AndoFlex TLC LS ASP-7905TLC-TN
EUDAMED
Class IActive
CoFlex TLC Zinc Standard 8840UBZ-SC-INTL
EUDAMED
Class IActive
Silveri: Coflex Afd, Coflex Afd First Aid, Afd Pad Foam Dressing, Powerflex Afd Foam Dressings K083133
EUDAMEDFDA 510(k)
UActive
PowerFlex 5yard 3815BK-048
EUDAMED
Class IActive
CoFlex TLC Single Calamine UB840C-01
EUDAMEDFDA UDI
Class IActive
CoFlex TLC Single 7802TN-14 TLC
EUDAMED
Class IActive
Coflex 3300RB-024
EUDAMED
Class IActive
CoFlex TLC XL 7800TLC-XL-INTL
EUDAMED
Class IActive
AndoFlex TLC LS Lite ASP-7907TLC-TN
EUDAMED
Class IActive
AndoFlex TLC Lite ASP-7807TLC-TN
EUDAMEDFDA UDI
Class IActive
Coflex Med 7600TN-012
EUDAMED
Class IActive
AndoFlex TLC XL ASP-7805TLC-XL
EUDAMEDFDA UDI
Class IActive
Coflex Nl 5150CP-048
EUDAMEDFDA UDI
Class IActive
AndoFlex TLC ASP-7805TLC-TN
EUDAMEDFDA UDI
Class IActive
CoFlex TLC Zinc 8840UBZ-TN-INTL
EUDAMED
Class IActive
CoFlex LF2 9400CP-018
EUDAMEDFDA UDI
Class IActive
Coflex Tlc Lite 7802TN-022
EUDAMED
Class IActive
CoFlex TLC Calamine 8830UBC-TN-INTL
EUDAMED
Class IActive
Coflex Afd 9740TN-08
EUDAMED
Class IActive
AndoFlex Zinc Single ASP-UB840Z-01
EUDAMED
Class IActive

Related Companies

Authorised Representatives

Importers

Not available yet.

Notified Bodies

Not available yet.

Authorities

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FDA Recalls (7)

Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.

DateRecall No.ClassStatusReason
Apr 2, 2024Z-1828-2024—open, classified

A packaging seal gap could impact the sterility of the product.

Jun 19, 2019Z-0179-2020—terminated

Incomplete packaging seal of sterile product

Jun 19, 2019Z-0181-2020—terminated

Incomplete packaging seal of sterile product

Jun 19, 2019Z-0183-2020—terminated

Incomplete packaging seal of sterile product

Jun 19, 2019Z-0184-2020—terminated

Incomplete packaging seal of sterile product

Jun 19, 2019Z-0180-2020—terminated

Incomplete packaging seal of sterile product

Jun 19, 2019Z-0182-2020—terminated

Incomplete packaging seal of sterile product