Identity
- Device Name
- Solid Gel Relief Cap Set EUDAMED
- Model / Reference
- ACBM04 EUDAMED/ EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06973589093098 EUDAMED
- Basic UDI-DI
- B-06973589093098 EUDAMED697358909BKBM01QJ EUDAMED
- Direct Marketing DI
- 06973589093098 EUDAMED
- EMDN Code
- M9001 CRYOTHERAPY AND THERMOTHERAPY DEVICES EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Denmark 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
Solid Gel Relief Cap Set by Wuhan Pakcare Bio‐technology Co., Ltd. — Class I — MDR, MDD — listed in EUDAMED — regulatory data on deviCERTS
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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 | B-06973589093098 | Class I | Active |
| EUDAMED | European Union | CE/MDD | B-06973589093098 | 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 (2)
- EUDAMED fa3ea36e-85eb-4a10-a7df-e90f4492125e 61 fields · synced Oct 6, 2026
- EUDAMED 583359e0-5223-4f90-ba3f-2da17a93d0b1 61 fields · synced May 17, 2026