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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 2 of 3
DeviceModel / ReferenceRegistriesClassStatus
Powerflex 6yd 3730GR-016
EUDAMED
Class IActive
Powerflex 6yd 3720TN-024
EUDAMED
Class IActive
AndoFlex TLC Calamine Standard ASP-8830UBC-SC
EUDAMED
Class IActive
Powerflex 6yd 3720RD-024
EUDAMED
Class IActive
AndoFlex TLC Zinc Standard ASP-8830UBZ-SC
EUDAMED
Class IActive
AndoFlex TLC Calamine Lite ASP-8840UBC-TN
EUDAMED
Class IActive
Powerflex 6yd 3715WH-032
EUDAMED
Class IActive
Powerflex 6yd 3730BK-016
EUDAMED
Class IActive
CoFlex TLC Zinc 8830UBZ-TN-INTL
EUDAMED
Class IActive
Powerflex 6yd 3720BK-024
EUDAMED
Class IActive
Coflex Tlc Lite 7802TLC-TN-INTL
EUDAMED
Class IActive
Coflex Med 7600TN-080
EUDAMED
Class IActive
Coflex Med 7100TN-030
EUDAMED
Class IActive
AndoFlex TLC Calamine Lite ASP-8830UBC-TN
EUDAMED
Class IActive
Powerflex 6yd 3730WH-016
EUDAMED
Class IActive
Coflex Med 7150CP-048
EUDAMED
Class IActive
Coflex Med 7200TN-036
EUDAMED
Class IActive
Powerflex 6yd 3710BK-048
EUDAMED
Class IActive
Powerflex 6yd 3740BK-012
EUDAMED
Class IActive
Coflex TAN, 4" X 5 Yds
FDA UDI
Class IActive
CoFlex TLC LITE LY2 3" X 3.8Yds
FDA UDI
Class IActive
Ubz NL W/IND TN/WH 4"
FDA UDI
Class IActive
Coflex NL CPK, 1"X5Yds
FDA UDI
Class IActive
Ubz STD W/IN TN/WH 4"
FDA UDI
Class IActive
AndoFlex UBZ 4"W/IN TN 3
EUDAMEDFDA UDI
Class IActive
Ubz STD W/IN TN/WH 3"
FDA UDI
Class IActive
Coflex BLUE, 3"X 5 Yds
FDA UDI
Class IActive
Coflex TLC XL REG TN/LB 4"
FDA UDI
Class IActive
Coflex NL BLUE, 4" X 5 Yds
FDA UDI
Class IActive
Coflex NL KIDSPACK 2" X 5 Yds
FDA UDI
Class IActive
Coflex NL TAN 2" X 5Yds
FDA UDI
Class IActive
Ubc SINGLE RL 3" X 6
EUDAMEDFDA UDI
Class IActive
Coflex TAN 4" X 6.5 Yds
FDA UDI
Class IActive
Coflex NL CPK, 4" X 5 Yds
FDA UDI
Class IActive
CoFlex TLC LY1 FOAM 6" X 3 Yds
EUDAMEDFDA UDI
Class IActive
Coflex NL CPK, 2"X5Yds
FDA UDI
Class IActive
AndoFlex UBZ Zinc NL TAN 4
EUDAMEDFDA UDI
Class IActive
Coflex LF2 CP, 1",X,5,Yds
FDA UDI
Class IActive
CoFlex TLC LS LT TAN/LB 4"
FDA UDI
Class IActive
Ubc STD W/IN TN/PK 3"
FDA UDI
Class IActive
Ubc STD W/IN TN/PK 4"
FDA UDI
Class IActive
Coflex NL CPK, 3" X 5 Yds
FDA UDI
Class IActive
CoFlex TLC LT TN/LB W/IN 4"
FDA UDI
Class IActive
CoFlex TLC LITE LY2 1" X 3.8 Yds
EUDAMEDFDA UDI
Class IActive
Ubz NL W/IND TN/WH 3"
FDA UDI
Class IActive
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

Related Companies

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Importers

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Notified Bodies

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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