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hot cold pack
EUDAMEDFDA UDIClass I (EU MDR)
Ref criobellagelpack KM-HT700Ref KM-R54 Migraine Gel CapRef KM-CY4565Ref KM-HJ350Ref ELI-4080Ref KM-GL472Ref KM-JS0135Ref PPB-5065Ref KM-JS0121Ref KM-YDL2948Ref Hot Cold PackRef ELI-902Ref KM-JS0059Ref PPB-6090Ref KM-JS0092Ref KM-JS0137Ref KM-JS0136Ref KM-YDL2950Ref KM-YDL2949Ref PPB-5090Ref KM-BD5090Ref KM-GL364Ref KM-JS0109Ref KM-BD4560
Identity
- Trade Name
- Hot Cold Pack EUDAMEDmagicgel FDA UDI
- Generic Name
- Hot/cold therapy pack, reusable FDA UDI
- Device Name
- hot cold pack EUDAMED
- Model / Reference
- criobellagelpack KM-HT700 EUDAMEDKM-R54 Migraine Gel Cap EUDAMEDKM-CY4565 EUDAMEDKM-HJ350 EUDAMEDELI-4080 EUDAMEDKM-GL472 EUDAMEDKM-JS0135 EUDAMEDPPB-5065 EUDAMEDKM-JS0121 EUDAMEDKM-YDL2948 EUDAMEDHot Cold Pack EUDAMEDELI-902 EUDAMEDKM-JS0059 EUDAMEDPPB-6090 EUDAMEDKM-JS0092 EUDAMEDKM-JS0137 EUDAMEDKM-JS0136 EUDAMEDKM-YDL2950 EUDAMEDKM-YDL2949 EUDAMEDPPB-5090 EUDAMEDKM-BD5090 EUDAMEDKM-GL364 EUDAMEDKM-JS0109 EUDAMEDKM-BD4560 EUDAMEDEblackmigrainegelcap FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06975306620389 EUDAMED06975306627012 EUDAMEDFDA UDI06975306620495 EUDAMED06975306620075 EUDAMED06975306620587 EUDAMED06975306620402 EUDAMED06975306620303 EUDAMED06975306620501 EUDAMED06975306620242 EUDAMED06975306620181 EUDAMED06975306620082 EUDAMED06975306620570 EUDAMED06975306620266 EUDAMED06975306620525 EUDAMED06975306620259 EUDAMED06975306620297 EUDAMED06975306620310 EUDAMED06975306620211 EUDAMED06975306620204 EUDAMED06975306620198 EUDAMED06975306620518 EUDAMED06975306620464 EUDAMED06975306620396 EUDAMED06975306620228 EUDAMED06975306620457 EUDAMED
- Basic UDI-DI
- 697530662Hotcoldpack59 EUDAMED
- FDA Product Code
- KYR FDA UDI
- EMDN Code
- M9001 CRYOTHERAPY AND THERMOTHERAPY DEVICES EUDAMED
- GMDN Term
- Hot/cold therapy pack, reusable FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 880.6050 FDA UDI
- Market of Registration
- Spain EUDAMEDGermany EUDAMEDBelgium 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
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
No
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
hot cold pack by Anhui Kamt Ice Pack Co., Ltd. — 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 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
- HotCold Pack reusable — Bevaplast B.V. · Class I
- reusable cold hot gel pack for Ankle — Wuhan Pakcare Bio‐technology Co.,Ltd. · Class I
- ACCU-THERM — Medline Industries, LP · 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 | 697530662Hotcoldpack59 | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Anhui Kamt Ice Pack Co., Ltd.
- EUDAMED SRN
- CN-MF-000023062
- Authorised Representative
- SUNGO Europe B.V. NL-AR-000000247
Sources (26)
- EUDAMED 51a4e80c-30db-4a46-9f9d-2fa34ad58e96 61 fields · synced Aug 5, 2026
- EUDAMED 4d9adf28-3bb1-4742-9d39-2384c1393160 61 fields · synced May 18, 2026
- FDA UDI 020f36ca-bad2-4458-b7a1-b3ca742fffd2 32 fields · synced May 30, 2026
- EUDAMED 7746d007-2f14-462e-a776-a548b9ce66d1 61 fields · synced Jun 20, 2026
- EUDAMED c4e861aa-0605-4843-873d-78711422c510 61 fields · synced Jul 9, 2026
- EUDAMED 6e93faf0-7a9f-4a73-bb36-af1fa8fbe6fe 61 fields · synced Jul 9, 2026
- EUDAMED ff96ad28-c387-4734-b3a6-042397736e0c 61 fields · synced Jul 9, 2026
- EUDAMED adefc5f7-7768-43a9-ac0f-ffe2304dea6f 61 fields · synced Jul 9, 2026
- EUDAMED b8a47d3e-cf26-4182-ac9b-6e561e3a048e 61 fields · synced Jul 9, 2026
- EUDAMED ed6bff58-eebb-4d5b-ac4c-8fbb6bd6893e 61 fields · synced Jul 9, 2026
- EUDAMED 9d08233f-11c7-4d1a-b3ce-ebebcd6aa8ad 61 fields · synced Jul 9, 2026
- EUDAMED 11a7a43f-1ab2-4687-b97f-4d84d78e500e 61 fields · synced Jul 9, 2026
- EUDAMED 53049d76-70e7-4c5e-a2ae-cc8b4de3f138 61 fields · synced Jul 9, 2026
- EUDAMED 00d76c00-58e2-406e-af83-920c09a552f1 61 fields · synced Jul 9, 2026
- EUDAMED ad16fc54-48c8-4bf6-8bc6-67a9be15861d 61 fields · synced Jul 9, 2026
- EUDAMED e1f0912c-4325-49fb-bd6f-f478fef23ba1 61 fields · synced Jul 10, 2026
- EUDAMED b06d0d14-9c3e-4969-b778-880cf5f28d8d 61 fields · synced Jul 10, 2026
- EUDAMED 344508cb-0093-42df-bec8-82bafd8926b0 61 fields · synced Jul 10, 2026
- EUDAMED 0285ac7a-5e15-4167-aad4-fdcf74c98a9e 61 fields · synced Jul 12, 2026
- EUDAMED 847f9b5c-7af8-4ba3-9da5-c30923d7e652 61 fields · synced Jul 13, 2026
- EUDAMED 8cf99dd2-7864-4f50-8305-801061df3190 61 fields · synced Jul 13, 2026
- EUDAMED 45ae3cce-b3d5-48f2-afb4-74ed1640699d 61 fields · synced Jul 21, 2026
- EUDAMED 586862cc-8df2-4eb7-860d-100f34df9034 61 fields · synced Jul 23, 2026
- EUDAMED caf11189-2692-4a76-a970-a4317f95e790 61 fields · synced Jul 29, 2026
- EUDAMED 28caccbc-a72e-4ef8-94af-14af8cb792b1 61 fields · synced Aug 2, 2026
- EUDAMED 331195b6-6324-49c7-8264-24e4aa48d009 61 fields · synced Aug 5, 2026