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Reusable hot/cold pack for multi purpose
EUDAMEDClass I (EU MDR)
Ref CBKT06Model C502B0Ref BGMZ01Ref AGWB15Ref ABBB02Ref CBKT04Model AMRD01 Ref AMFX06Ref AMFX07
Identity
- Trade Name
- Reusable hot/cold pack for multi purpose EUDAMED
- Device Name
- Reusable Hot/cold packs EUDAMED
- Model / Reference
- C502B0 EUDAMEDCBKT06 EUDAMEDBGMZ01 EUDAMEDAGWB15 EUDAMEDABBB02 EUDAMEDCBKT04 EUDAMEDAMRD01 EUDAMEDAMFX06 EUDAMEDAMFX07 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06978920970496 EUDAMED06978920970236 EUDAMED06978920970533 EUDAMED06978920970229 EUDAMED06978920970489 EUDAMED06978920971820 EUDAMED06978920971837 EUDAMED
- Basic UDI-DI
- 697358909HP100MD EUDAMED697892097HP100Q6 EUDAMED
- Direct Marketing DI
- 06978920970496 EUDAMED06978920970236 EUDAMED06978920970533 EUDAMED06978920970229 EUDAMED06978920970489 EUDAMED06978920971820 EUDAMED06978920971837 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
Reusable hot/cold pack for multi purpose by Wuhan Pakcare Bio‐technology Co., Ltd. — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
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 (12)
- EUDAMED 09a5484e-8eda-4b8e-bb35-ab0a7ef7832a 61 fields · synced Oct 6, 2026
- EUDAMED d8305da0-6c54-4b6d-a1c9-326c78e2a9bf 61 fields · synced May 17, 2026
- EUDAMED 6d480eff-5d02-47f6-a009-7d437c9556af 61 fields · synced May 18, 2026
- EUDAMED d15bbba5-5c43-4693-8f74-c16ba20f7d40 61 fields · synced May 19, 2026
- EUDAMED 1c02ac03-4811-49c5-be0c-43a03e94579c 61 fields · synced May 19, 2026
- EUDAMED ad6e91a6-b23b-469d-8f34-61cf79235f7d 61 fields · synced Jun 11, 2026
- EUDAMED 1dcb9a68-49f1-4994-ab66-4b07da501cc5 61 fields · synced Jul 15, 2026
- EUDAMED daec0243-73dd-4598-98b5-9cf90935cf54 61 fields · synced Jul 15, 2026
- EUDAMED df22235d-1021-4864-8b39-f359c4da0a3f 61 fields · synced Jul 20, 2026
- EUDAMED 949e8b4e-ba1d-4773-a3ee-6c07f2287638 61 fields · synced Jul 22, 2026
- EUDAMED 9de96905-f3e2-48c7-ad1c-26e732b0952e 61 fields · synced Jul 25, 2026
- EUDAMED 778df56a-a708-41b9-bcb9-a7f5609ed7f6 61 fields · synced Jul 26, 2026