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Fiberglass Casting Tape
EUDAMEDClass I (EU MDR)
Ref AX006（150mm×3600mm）Model AX002
Identity
- Trade Name
- Fiberglass Casting Tape EUDAMED
- Device Name
- Fiberglass Casting Tape EUDAMED
- Model / Reference
- AX002 EUDAMEDAX006（150mm×3600mm） EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06970210232260 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 (1)
- EUDAMED ef89d1d0-fa2d-4653-b140-1eef7bc434f6 61 fields · synced Jun 18, 2026