Identity
- Trade Name
- CTC-7 FDA UDI
- Generic Name
- Circulating-fluid localized thermal therapy system pack, reusable FDA UDI
- Device Name
- Device(Black) 1ea, Hose 1ea, Assist band 1ea FDA UDI
- Model / Reference
- CTC-7 EUDAMEDCTC7201 EUDAMEDFDA UDI
- Description
- Device(Black) 1ea, Hose 1ea, Assist band 1ea FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08809315679244 EUDAMEDFDA UDI
- Basic UDI-DI
- B-08809315679244 EUDAMED
- FDA Product Code
- ILO FDA UDI
- EMDN Code
- M9001 CRYOTHERAPY AND THERMOTHERAPY DEVICES EUDAMED
- GMDN Term
- Circulating-fluid localized thermal therapy system pack, reusable FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 890.5720 FDA UDI
- Market of Registration
- France EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
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
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Hot/cold therapy pack, reusable
Ctc7201 by Daesung Maref Co., Ltd. — Class IIa — MDD, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
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Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-08809315679244 | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- Daesung Maref Co., Ltd.
- EUDAMED SRN
- KR-MF-000008616
- Authorised Representative
- KTR Europe GmbH DE-AR-000005685
Sources (2)
- EUDAMED bc61c427-72e9-476d-b243-1523d04ca555 61 fields · synced Jul 8, 2026
- FDA UDI 3bf0ad1a-19c5-4702-9060-6c8127045475 33 fields · synced May 30, 2026