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Strap If Pad Compression
EUDAMEDFDA UDIClass I (EU MDR)
Ref 10670Model DOC 901-01 COLD THEARPY PAD ACCESSORIES
by Breg, Inc.
Identity
- Trade Name
- STRAP IF PAD COMPRESSION EUDAMEDBREG FDA UDI
- Generic Name
- Circulating-fluid localized thermal therapy system pack, single-use FDA UDI
- Model / Reference
- DOC 901-01 COLD THEARPY PAD ACCESSORIES EUDAMED10670 EUDAMEDSTRAP IF PAD COMPRESSION FDA UDI
Identifiers
- Catalog Number
- 10670 FDA UDI
- Primary DI / UDI-DI
- 00672736000670 EUDAMEDFDA UDI
- Basic UDI-DI
- 06727360005792 EUDAMED
- FDA Product Code
- ILO FDA UDI
- EMDN Code
- M9001 CRYOTHERAPY AND THERMOTHERAPY DEVICES EUDAMED
- GMDN Term
- Circulating-fluid localized thermal therapy system pack, single-use FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 890.5720 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
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
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Hot/cold therapy pack, reusable
Strap If Pad Compression by Breg, Inc. — Class I — MDR, 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/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 06727360005792 | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Breg, Inc.
- EUDAMED SRN
- US-MF-000018362
- Authorised Representative
- MDSS GmbH DE-AR-000005430
Sources (2)
- EUDAMED 7f6faa49-0b38-4df3-be23-9888515d0076 61 fields · synced Aug 2, 2026
- FDA UDI fb7b575a-ebf8-4c5e-9694-e65e2c3c0aaf 34 fields · synced May 30, 2026