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Fiberglass Casting Tape
EUDAMEDClass I (EU MDR)
Ref AX004（100mm×3600mm）Model AX002Ref AX003（75mm×3600mm）Ref AX005（125mm×3600mm）
Identity
- Trade Name
- Fiberglass Casting Tape EUDAMED
- Device Name
- Fiberglass Casting Tape EUDAMED
- Model / Reference
- AX002 EUDAMEDAX004（100mm×3600mm） EUDAMEDAX003（75mm×3600mm） EUDAMEDAX005（125mm×3600mm） EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06970210232246 EUDAMED06970210232239 EUDAMED06970210232253 EUDAMED
- Basic UDI-DI
- 697021023AX00139 EUDAMED
- EMDN Code
- M03050202 SYNTHETIC CAST BANDAGES AND SPLINTS 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
Category: Cotton wool roll, sterile
Fiberglass Casting Tape by Shaanxi Ansen Medical Technology Development Co., Ltd — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
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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 | 697021023AX00139 | Class I | Active |
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Manufacturer
- EUDAMED SRN
- CN-MF-000050669
- Authorised Representative
- RIOMAVIX SOCIEDAD LIMITADA ES-AR-000001202
Sources (3)
- EUDAMED e9edebc1-63c4-46f9-ae6d-0bb036d9cb11 61 fields · synced Jul 29, 2026
- EUDAMED 71e25a7c-bd3c-4545-9680-ad29bef9ba70 61 fields · synced May 18, 2026
- EUDAMED ff6b8d44-1a35-49fd-990d-3a482ee430bd 61 fields · synced May 19, 2026