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Orthopedic Casting Tape
EUDAMEDFDA UDIClass I (EU MDR)
Ref -Model XD1,XD2,XD3,XD4,XD5,XD6
Identity
- Trade Name
- Senolo FDA UDI
- Generic Name
- Cast construction material FDA UDI
- Device Name
- Orthopedic Casting Tape EUDAMED
- Model / Reference
- XD1,XD2,XD3,XD4,XD5,XD6 EUDAMED- EUDAMEDXD2 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 16952534411122 EUDAMEDFDA UDI
- Basic UDI-DI
- 69525344CAST100MU EUDAMED
- FDA Product Code
- ITG FDA UDI
- EMDN Code
- M03050202 SYNTHETIC CAST BANDAGES AND SPLINTS EUDAMED
- GMDN Term
- Cast construction material FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 890.3025 FDA UDI
- Market of Registration
- Italy EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
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
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Cotton wool roll, sterile
Orthopedic Casting Tape by Jiangsu Senolo Medical Technology Co., Ltd. — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
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Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 69525344CAST100MU | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Jiangsu Senolo Medical Technology Co., Ltd.
- EUDAMED SRN
- CN-MF-000008281
- Authorised Representative
- SUNGO Europe B.V. NL-AR-000000247
Sources (2)
- EUDAMED 7cf1245d-33d6-4435-b1b9-275597b0e28d 61 fields · synced Jul 9, 2026
- FDA UDI 427a3f3a-fb8b-4571-975d-b6f2e6299a99 32 fields · synced May 30, 2026