Identity
- Trade Name
- SPOPHY EUDAMED
- Device Name
- Athletic Tape EUDAMED
- Model / Reference
- Cotton EUDAMEDZhe Hang Xie Bei 20150235 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06931346750080 EUDAMED
- Basic UDI-DI
- 69313467SP001N4 EUDAMED
- Direct Marketing DI
- 06931346750080 EUDAMED
- EMDN Code
- M030403 FUNCTIONAL BANDAGES WITH ANELASTIC TAPES 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 | 69313467SP001N4 | 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 79b662ea-3ac6-49c1-8264-0b2e41c15683 61 fields · synced Sep 17, 2026