← Back to catalogue
Orthopedic Splint
EUDAMEDFDA UDIClass I (EU MDR)
Ref -Model XB1,XB2,XB3,XB4,XB5,XB6,XB212,XB224,XB312,XB316,XB320,XB324,XB328,XB336,XB416,XB418,XB420,XB428,XB430,XB436,XB528,XB530,XB536,XB545,XB546,XB548,XB630,XB636,XB646,XB648
Identity
- Trade Name
- Senolo FDA UDI
- Generic Name
- First aid limb splint, non-mouldable, single-use FDA UDI
- Device Name
- Orthopedic Splint EUDAMED
- Model / Reference
- XB1,XB2,XB3,XB4,XB5,XB6,XB212,XB224,XB312,XB316,XB320,XB324,XB328,XB336,XB416,XB418,XB420,XB428,XB430,XB436,XB528,XB530,XB536,XB545,XB546,XB548,XB630,XB636,XB646,XB648 EUDAMED- EUDAMEDXB312 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 16952534421114 EUDAMEDFDA UDI
- Basic UDI-DI
- 69525344SPLINT200XV EUDAMED
- FDA Product Code
- HSP FDA UDI
- EMDN Code
- M03050202 SYNTHETIC CAST BANDAGES AND SPLINTS EUDAMED
- GMDN Term
- First aid limb splint, non-mouldable, single-use FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 888.5890 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 Splint by Jiangsu Senolo Medical Technology Co., Ltd. — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Cotton wool roll, sterile.
- Medical Splint — Anping Guardian Medical Equipment Co., Ltd · Class I
- Delta-Dry® — BSN MEDICAL, INC. · Class I
- JERSEY TUBULAIRE HYDROFUGE 25cm x 25m — MAILL'TUB · Class I
- Rolyan Sof-Stretch Extension Splint, White, X-Small, 1/EA — Performance Health Supply, LLC · Class I
- Tricofix® — BSN MEDICAL, INC. · Class I
- Delta-Lite® Plus — BSN MEDICAL, INC. · Class I
- NOBACAST®-GRÜN 7, 5 CM 3, 6M — NOBAMED Paul Danz AG · Class I
- ROLYAN THERMOPLASTIC SHEET — Performance Health Supply, LLC · Class I
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 | 69525344SPLINT200XV | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
Is this your device? Claim it to add documentation and request validation.
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 eb02939d-28bb-4309-80c7-6894113a5a6d 61 fields · synced Jul 18, 2026
- FDA UDI acf56faf-d60b-447f-b91a-75b6d4bc16db 32 fields · synced May 30, 2026