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doc THERMA WÄRME-AUFLAGE FLEX
EUDAMEDClass IIa (EU MDR)
Ref PZN-20306327Ref 11595Ref 11604Ref 11596
Identity
- Trade Name
- doc THERMA WÄRME-AUFLAGE FLEX EUDAMED
- Device Name
- X Heat Patch EUDAMED
- Model / Reference
- PZN-20306327 EUDAMED11595 EUDAMED11604 EUDAMED11596 EUDAMED
Identifiers
- Primary DI / UDI-DI
- D-000030482HMSXPPN EUDAMEDD-CN-MF-000030482HMSXHPF8 EUDAMEDD-CN-MF-000030482HMSXHSFE EUDAMEDD-CN-MF-000030482HMSXH4DJ EUDAMED
- Basic UDI-DI
- B-000030482HMSXPPN EUDAMEDB-CN-MF-000030482HMSXHPF8 EUDAMEDB-CN-MF-000030482HMSXHSFE EUDAMEDB-CN-MF-000030482HMSXH4DJ EUDAMED
- EMDN Code
- M9001 CRYOTHERAPY AND THERMOTHERAPY DEVICES EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Category: Hot/cold therapy pack, reusable
doc THERMA WÄRME-AUFLAGE FLEX by Jiangsu Hanyao Medical Devices Co., Ltd — Class IIa — 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/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-000030482HMSXPPN | Class IIa | Active |
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Manufacturer
- Manufacturer
- Jiangsu Hanyao Medical Devices Co., Ltd
- EUDAMED SRN
- CN-MF-000030482
- Authorised Representative
- HÄLSA Pharma GmbH DE-AR-000007406
Sources (4)
- EUDAMED 26fb9397-cf3f-486d-9c71-30b7a117ee87 61 fields · synced Jul 20, 2026
- EUDAMED 84ca25dd-0463-4fed-9e3a-4685c1861a02 61 fields · synced Jul 9, 2026
- EUDAMED ae7ce48c-d414-44cf-bd13-d7e186852e64 61 fields · synced Jul 12, 2026
- EUDAMED d0b0fefb-5401-4a55-b4bf-ada545279966 61 fields · synced Jul 20, 2026