Identity
- Trade Name
- Delta Zero Phantom Bandage EUDAMED
- Device Name
- Sterile Bandage EUDAMED
- Model / Reference
- TPS SB01 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06977143460500 EUDAMED
- Basic UDI-DI
- 697714346TPSSB01AB EUDAMED
- EMDN Code
- M0304010101 ELASTIC COMPRESSION BANDAGES, NON-ADHESIVE, LOW EXTENSIBILITY (<70%) EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
Yes
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
Delta Zero Phantom Bandage by Hangzhou Tuopusi Medical Products 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 | 697714346TPSSB01AB | Class I | Active |
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Manufacturer
- Manufacturer
- Hangzhou Tuopusi Medical Products Co., Ltd
- EUDAMED SRN
- CN-MF-000039733
- Authorised Representative
- Caretechion GmbH DE-AR-000005946
Sources (1)
- EUDAMED c3bae9e9-38e6-4d44-b097-0ad3cd1b485b 61 fields · synced Jun 19, 2026