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Kohezyjna opaska podtrzymująca Heltiso 4cmx4cm
EUDAMEDClass I (EU MDR)
Ref HE-CB004400 inner box
Identity
- Trade Name
- Kohezyjna opaska podtrzymująca Heltiso 4cmx4cm EUDAMED
- Device Name
- BODYBOW FLEXTAPE EUDAMED
- Model / Reference
- HE-CB004400 inner box EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06973864855557 EUDAMED
- Basic UDI-DI
- 697386485BODYBOWCOHESIVV3 EUDAMED
- Direct Marketing DI
- 06973864855557 EUDAMED
- EMDN Code
- M0303010101 ELASTIC FIXING BANDAGES, NON-ADHESIVE, EXTENSIBLE IN ONE DIRECTION EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Poland EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
Yes
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
Kohezyjna opaska podtrzymująca Heltiso 4cmx4cm by Suzhou Sunmed 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 | 697386485BODYBOWCOHESIVV3 | Class I | Active |
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Manufacturer
- Manufacturer
- Suzhou Sunmed Co., Ltd.
- EUDAMED SRN
- CN-MF-000010170
- Authorised Representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Sources (1)
- EUDAMED aaa4e8be-3209-4620-95a6-033f16c035f7 61 fields · synced Oct 5, 2026