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Hot and cold pack
EUDAMEDClass I (EU MDR)
Ref N/AModel ZN1W2S9Model M500B1Ref ABFX16Model C502B0Model ZN4W4S5Ref ABFX09Model AMRD01
Identity
- Trade Name
- Hot and cold pack EUDAMEDhot and cold pack -S EUDAMED
- Device Name
- Medcosa Gel Sock Ice Pack EUDAMEDMulti-zone cooling/ heating pack EUDAMEDReusable Hot/cold packs EUDAMEDMedcosa Heat Glove Pack (Flaxseed) EUDAMED
- Model / Reference
- ZN1W2S9 EUDAMEDN/A EUDAMEDM500B1 EUDAMEDC502B0 EUDAMEDABFX16 EUDAMEDZN4W4S5 EUDAMEDAMRD01 EUDAMEDABFX09 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06973589090615 EUDAMED06973589090165 EUDAMED06978920970274 EUDAMED06973589090653 EUDAMED06978920972391 EUDAMED
- Basic UDI-DI
- B-06973589090615 EUDAMEDB-06973589090165 EUDAMED697358909HP100MD EUDAMEDB-06973589090653 EUDAMED697892097HP100Q6 EUDAMED
- Direct Marketing DI
- 06978920970274 EUDAMED06978920972391 EUDAMED
- EMDN Code
- M9001 CRYOTHERAPY AND THERMOTHERAPY DEVICES EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Netherlands EUDAMEDGermany 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
Hot and cold pack by Wuhan Pakcare Bio‐technology Co., Ltd. — Class I — MDR, MDD — listed in EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Hot/cold therapy pack, reusable.
- Future Generation Medical — Global International L. L. C. · Class I
- PRONTO MED — Eurosirel Spa · Class IIa
- hot cold pack — Anhui Kamt Ice Pack Co.,Ltd. · Class I
- ACCU-THERM — Medline Industries, LP · Class I
- HotCold Pack reusable — Bevaplast B.V. · Class I
- ACCU-THERM — Medline Industries, LP · Class I
- Krioboost — EURONDA S.P.A. · Class IIa
- PRONTO DOC — Eurosirel Spa · Class IIa
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 | B-06973589090615 | Class I | Active |
| EUDAMED | European Union | CE/MDD | B-06973589090615 | Class I | Active |
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Manufacturer
- Manufacturer
- Wuhan Pakcare Bio‐technology Co., Ltd.
- EUDAMED SRN
- CN-MF-000008960
- Authorised Representative
- SUNGO Europe B.V. NL-AR-000000247
Sources (6)
- EUDAMED a3138e47-53dd-4317-adba-4d60a69c3a99 61 fields · synced Oct 6, 2026
- EUDAMED 522cfa8e-a8a4-4e32-b03f-5fadb43e315c 61 fields · synced May 17, 2026
- EUDAMED 45b2a628-1d87-4add-88c4-b5b170a44a2c 61 fields · synced May 19, 2026
- EUDAMED 18142f2c-a3df-40c9-9163-143cdef39677 61 fields · synced May 19, 2026
- EUDAMED 53290e55-28d0-404f-9e49-69f9f4634ed7 61 fields · synced Jul 11, 2026
- EUDAMED c2e6bbfe-c755-45b9-9391-6236f696f7f4 61 fields · synced Jul 18, 2026