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Breg Cold Compression Pad, Knee
EUDAMEDFDA UDIClass I (EU MDR)
Ref C00017Model DOC 801-01 COLD COMPRESSION PAD ACCESSORIES
by Breg, Inc.
Identity
- Trade Name
- BREG COLD COMPRESSION PAD, KNEE EUDAMEDBREG FDA UDI
- Generic Name
- Inflatable hot/cold therapy pack/electric pump FDA UDI
- Device Name
- BREG COLD COMPRESSION PAD, KNEE FDA UDI
- Model / Reference
- DOC 801-01 COLD COMPRESSION PAD ACCESSORIES EUDAMEDC00017 EUDAMEDVPULSE THERM COMP PAD KNEE FDA UDI
- Description
- BREG COLD COMPRESSION PAD, KNEE FDA UDI
Identifiers
- Catalog Number
- C00017 FDA UDI
- Primary DI / UDI-DI
- 00672736065112 EUDAMEDFDA UDI
- Basic UDI-DI
- 06727360005894 EUDAMED
- 510(k) Number
- K122640 FDA UDI
- FDA Product Code
- JOW 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
- 870.5800 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
No
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
Breg Cold Compression Pad, Knee by Breg, Inc. — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Hot/cold therapy pack, reusable.
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- HOT/COLD THERAPEUTIC PACK FOR KNEE — Wuhan Pakcare Bio‐technology Co.,Ltd. · Class I
- hot cold pack — Anhui Kamt Ice Pack Co.,Ltd. · Class I
- HotCold Pack reusable — Bevaplast B.V. · Class I
- reusable cold hot gel pack for Ankle — Wuhan Pakcare Bio‐technology Co.,Ltd. · Class I
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 | 06727360005894 | 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 71feeb5c-a02e-4b30-bf62-de9bda5c929c 61 fields · synced Jun 19, 2026
- FDA UDI a8ce4230-accd-4085-b0c3-ffe823509630 36 fields · synced May 30, 2026