Identity
- Trade Name
- SPOPHY EUDAMED
- Device Name
- Cohesive Bandage EUDAMED
- Model / Reference
- Biodegradable EUDAMEDZHE HANG XIE BEI20170252 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06931346750233 EUDAMED
- Basic UDI-DI
- 69313467DEB001BX EUDAMED
- Direct Marketing DI
- 06931346750233 EUDAMED
- EMDN Code
- M0303010201 ELASTIC FIXING BANDAGES, SELF-ADHESIVE, EXTENSIBLE IN ONE DIRECTION EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Czechia 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
Spophy by Hangzhou GspMed Medical Appliances 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 | 69313467DEB001BX | Class I | Active |
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Manufacturer
- Manufacturer
- Hangzhou Gspmed Medical Appliances Co., Ltd.
- EUDAMED SRN
- CN-MF-000018891
- Authorised Representative
- Prolinx GmbH DE-AR-000005129
Sources (1)
- EUDAMED 206e748e-4310-4ea7-9b1a-187126ed85ae 61 fields · synced Jul 8, 2026