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Gel Ice Cap with eye mask set
EUDAMEDClass I (EU MDR)
Ref AMMZ03Model C502B0Ref AGTZ13Model AMRD01
Identity
- Trade Name
- Gel Ice Cap with eye mask set EUDAMEDHOT/COLD GEL PACK EUDAMED
- Device Name
- Reusable Hot/cold packs EUDAMED
- Model / Reference
- C502B0 EUDAMEDAMMZ03 EUDAMEDAMRD01 EUDAMEDAGTZ13 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06978920970502 EUDAMED06978920972667 EUDAMED
- Basic UDI-DI
- 697358909HP100MD EUDAMED697892097HP100Q6 EUDAMED
- Direct Marketing DI
- 06978920970502 EUDAMED06978920972667 EUDAMED
- EMDN Code
- M9001 CRYOTHERAPY AND THERMOTHERAPY DEVICES EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Germany 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
Gel Ice Cap with eye mask set by Wuhan Pakcare Bio‐technology Co., Ltd. — Class I — MDR — 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
- 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
- Kit de cryothérapie périnéale règles douloureuses — ORTHOMEDICA · Class I
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 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 (3)
- EUDAMED bf83dd2f-1aee-49bb-ae60-0c0f878c0658 61 fields · synced Jul 10, 2026
- EUDAMED c3adef7c-bd1b-437b-aa52-f72cf1043c76 61 fields · synced Jun 18, 2026
- EUDAMED 713ec7d5-f908-4235-b76d-8e05e1a3333d 61 fields · synced Jul 10, 2026