Breg Cold Compression Pad, Shoulder
EUDAMEDFDA UDIClass I (EU MDR)
by Breg, Inc.
Identity
- Trade Name
- BREG COLD COMPRESSION PAD, SHOULDER EUDAMEDBREG FDA UDI
- Generic Name
- Inflatable hot/cold therapy pack/electric pump FDA UDI
- Device Name
- BREG COLD COMPRESSION PAD, SHOULDER FDA UDI
- Model / Reference
- DOC 801-01 COLD COMPRESSION PAD ACCESSORIES EUDAMEDC00004 EUDAMEDVPULSE THERM COMP PAD SHLDR FDA UDI
- Description
- BREG COLD COMPRESSION PAD, SHOULDER FDA UDI
Identifiers
- Catalog Number
- C00004 FDA UDI
- Primary DI / UDI-DI
- 00672736064962 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
Single Use
Yes
Implantable
No
Reusable
No
Contains Latex
No
Reprocessed
No
CMR Substance
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
Prescription Use
Yes
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
No
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
No
Manufacturing Date
Yes
Category: Hot/cold therapy pack, reusable
Breg Cold Compression Pad, Shoulder 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.
- Future Generation Medical — Global International L. L. C. · Class I
- Hot Cold Pack - Universal customized Cartoon pack Jurassic & Gabby's Dollhouse — Wuhan Pakcare Bio‐technology Co.,Ltd. · Class I
- HOT/COLD THERAPY SLIPPER — Wuhan Pakcare Bio‐technology Co.,Ltd. · Class I
- PRONTO MED — Eurosirel Spa · Class IIa
- 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
CE/MDR
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Breg, Inc.
- EUDAMED SRN
- US-MF-000018362
- Authorised Representative
- MDSS GmbH DE-AR-000005430
Sources (2)
- EUDAMED cdf856a6-390d-497c-bdc2-4109fb65a0ef 61 fields · synced Jun 20, 2026
- FDA UDI 06a92750-cab7-426b-8904-fb317f7bc5ba 36 fields · synced May 30, 2026