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Cuff
EUDAMEDClass I (EU MDR)
Ref 06978034830112Model E(32-48cm)Ref 06978034830013Model JH-1004, JH-1003, JH-1005, JH-1006, JH-1001, JH-1009Ref 06978034830082Model B(22-36cm)
Identity
- Device Name
- CUFF EUDAMED
- Model / Reference
- E(32-48cm) EUDAMED06978034830112 EUDAMEDJH-1004, JH-1003, JH-1005, JH-1006, JH-1001, JH-1009 EUDAMED06978034830013 EUDAMEDB(22-36cm) EUDAMED06978034830082 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06978034830112 EUDAMED06978034830013 EUDAMED06978034830082 EUDAMED
- Basic UDI-DI
- 6978034830112BS EUDAMED6978034830013BP EUDAMED6978034830082CA EUDAMED
- EMDN Code
- V9099 VARIOUS DEVICES NOT INCLUDED IN OTHER CLASSES - OTHER EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Spain 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: Device sterilization/disinfection container, reusable
Cuff by Hubei Jianhua Technology Co., Ltd. — Class I — MDR — 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
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 6978034830112BS | Class I | Active |
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Manufacturer
- Manufacturer
- Hubei Jianhua Technology Co., Ltd.
- EUDAMED SRN
- CN-MF-000044837
- Authorised Representative
- REP Europe GmbH DE-AR-000025090
Sources (3)
- EUDAMED a312a219-fd9b-4d3e-a74d-c8641ba60ee3 61 fields · synced Sep 17, 2026
- EUDAMED de3e32f2-352e-4683-88a8-4256b9204752 61 fields · synced May 17, 2026
- EUDAMED 28ff56bb-deb7-4c2d-bd47-712c38322582 61 fields · synced May 18, 2026