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Ctc-7

FDA UDIEUDAMED

Class II (US FDA UDI)

by Daesung Maref Co., Ltd.

Identity

Trade Name
CTC-7 FDA UDI
Generic Name
Circulating-fluid localized thermal therapy system pack, reusable FDA UDI
Device Name
Reusable shoulder wrap 1ea FDA UDI
Model / Reference
CTCSM00 FDA UDI
Description
Reusable shoulder wrap 1ea FDA UDI

Identifiers

Primary DI / UDI-DI
08809315679442 FDA UDI
FDA Product Code
ILO FDA UDI
GMDN Term
Circulating-fluid localized thermal therapy system pack, reusable FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
890.5720 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Circulating-fluid localized thermal therapy system pack, reusable

Ctc-7 by Daesung Maref Co., Ltd. — Class II — MDD, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS

Similar devices

Also classified as Circulating-fluid localized thermal therapy system pack, reusable.

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Unknown

MDD

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Daesung Maref Co., Ltd.

Sources (2)

  • FDA UDI 09596476-d4db-453a-8d0a-d1f26c7463f5 33 fields · synced Jun 9, 2026
  • EUDAMED 1 fields · synced Jun 2, 2026