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Cold Pack -gel Pack
EUDAMEDClass I (EU MDR)
Ref AGFX10Model C502B0Ref ABFX19Ref N/AModel E040C2Ref CCKT34Model M515L4Model M513L4Ref CCKT35Model AMRD01 Ref CCKT44Ref CCKT36Ref CCKT38Ref CCKT39
Identity
- Trade Name
- COLD PACK -GEL PACK EUDAMEDHOT COLD PACK EUDAMEDHot Cold Pack - Universal customized Cartoon pack Jurassic & Gabby's Dollhouse EUDAMED
- Device Name
- Reusable Hot/cold packs EUDAMEDHOT& COLD CLAY EYE MASK, MEDIUM SIZE EUDAMEDMEDIUM SIZE CLAY MUD PACK EUDAMEDOVER-LARGE SIZE GEL PACK EUDAMED
- Model / Reference
- C502B0 EUDAMEDAGFX10 EUDAMEDABFX19 EUDAMEDE040C2 EUDAMEDN/A EUDAMEDCCKT34 EUDAMEDM515L4 EUDAMEDM513L4 EUDAMEDAMRD01 EUDAMEDCCKT35 EUDAMEDCCKT44 EUDAMEDCCKT36 EUDAMEDCCKT38 EUDAMEDCCKT39 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06978920970359 EUDAMED06978920970380 EUDAMED06973589090943 EUDAMED06973589092831 EUDAMED06973589090974 EUDAMED06973589090967 EUDAMED06978920972438 EUDAMED06978920972421 EUDAMED06978920971974 EUDAMED06978920972445 EUDAMED06978920972469 EUDAMED06978920972476 EUDAMED
- Basic UDI-DI
- 697358909HP100MD EUDAMEDB-06973589090943 EUDAMEDB-06973589090974 EUDAMEDB-06973589090967 EUDAMED697892097HP100Q6 EUDAMED
- Direct Marketing DI
- 06978920970359 EUDAMED06978920970380 EUDAMED06973589092831 EUDAMED06978920972438 EUDAMED06978920972421 EUDAMED06978920971974 EUDAMED06978920972445 EUDAMED06978920972469 EUDAMED06978920972476 EUDAMED
- EMDN Code
- M9001 CRYOTHERAPY AND THERMOTHERAPY DEVICES EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Germany EUDAMEDNetherlands EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
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
Category: Hot/cold therapy pack, reusable
Cold Pack -gel Pack by Wuhan Pakcare Bio‐technology Co., Ltd. — Class I — MDR, MDD — listed in EUDAMED — regulatory data on deviCERTS
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Also classified as Hot/cold therapy pack, reusable.
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Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 697358909HP100MD | Class I | Active |
| EUDAMED | European Union | CE/MDD | 697358909HP100MD | Class I | Active |
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Manufacturer
- Manufacturer
- Wuhan Pakcare Bio‐technology Co., Ltd.
- EUDAMED SRN
- CN-MF-000008960
- Authorised Representative
- Share info GmbH DE-AR-000005132
Sources (14)
- EUDAMED 7c247dc1-13b1-4c08-a0ca-2e6456a75c18 61 fields · synced Jul 27, 2026
- EUDAMED 19ff3a23-ed6e-4674-84c4-eb7575c5a147 61 fields · synced May 17, 2026
- EUDAMED c4a4cebd-548a-4ed0-9893-15d7064bd679 61 fields · synced May 17, 2026
- EUDAMED 47a4467e-d40f-4ef8-8de9-8f281df8ac88 61 fields · synced May 18, 2026
- EUDAMED 7bf57a3f-7bd0-4350-85cb-d6d2ba577d51 61 fields · synced May 18, 2026
- EUDAMED 404db0e6-8eda-471d-a5fd-02ca2724e72b 61 fields · synced May 18, 2026
- EUDAMED 5464e74e-3a5f-42c2-b0bb-9b0d780f2551 61 fields · synced Jul 8, 2026
- EUDAMED c929a1b6-5bbd-44c2-94bd-c2a948255911 61 fields · synced Jul 9, 2026
- EUDAMED a53ad3e5-d8d4-4907-bc92-aa68524888e1 61 fields · synced Jul 9, 2026
- EUDAMED cae47e52-dcca-46b2-a0be-1518cab61e62 61 fields · synced Jul 10, 2026
- EUDAMED 65c8f0fd-0544-4513-9f75-efb528718a6b 61 fields · synced Jul 16, 2026
- EUDAMED 0c4e3b73-5c78-4480-957b-b716fe4413f1 61 fields · synced Jul 17, 2026
- EUDAMED 7085dd08-f71e-4fe5-9065-74403ee6fc11 61 fields · synced Jul 24, 2026
- EUDAMED ccdac409-3db7-4572-9661-b413d2f4bf2c 61 fields · synced Jul 27, 2026