Identity
- Device Name
- DVT sleeves EUDAMED
- Model / Reference
- H4 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06975871861583 EUDAMED
- Basic UDI-DI
- 697587186DW001PN EUDAMED
- EMDN Code
- Z12069080 VARIOUS PHYSIOTHERAPY AND REHABILITATION INSTRUMENTS - HARDWARE ACCESSORIES 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
DVT sleeves by Ningbo KK-Bioscience 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 | 697587186DW001PN | Class I | Active |
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Manufacturer
- Manufacturer
- Ningbo KK-Bioscience Co., Ltd.
- EUDAMED SRN
- CN-MF-000016962
- Authorised Representative
- Humiss International B.V. NL-AR-000001490
Sources (1)
- EUDAMED b893a58f-c642-4dd1-a200-c6862fbc6262 61 fields · synced Jun 19, 2026