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If Pad Back Intl
EUDAMEDFDA UDIClass I (EU MDR)
Ref 100300-000Model DOC 901-01 COLD THEARPY PAD ACCESSORIES
by Breg, Inc.
Identity
- Trade Name
- IF PAD BACK INTL EUDAMEDBREG FDA UDI
- Generic Name
- Inflatable hot/cold therapy pack/electric pump FDA UDI
- Model / Reference
- DOC 901-01 COLD THEARPY PAD ACCESSORIES EUDAMED100300-000 EUDAMEDIF PAD BACK INTL FDA UDI
Identifiers
- Catalog Number
- 100300-000 FDA UDI
- Primary DI / UDI-DI
- 00672736026786 EUDAMEDFDA UDI
- Basic UDI-DI
- 06727360005792 EUDAMED
- FDA Product Code
- ILO FDA UDI
- EMDN Code
- M9001 CRYOTHERAPY AND THERMOTHERAPY DEVICES EUDAMED
- GMDN Term
- Inflatable hot/cold therapy pack/electric pump 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
If Pad Back Intl by Breg, Inc. — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
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 14638f7c-ada1-46e3-baef-b85a91f7cf2b 61 fields · synced Jun 18, 2026
- FDA UDI c88fd53a-74b2-4751-8cf5-d3c90ce726b6 34 fields · synced May 30, 2026