Identity
- Trade Name
- Medical polymer splint EUDAMEDRTMED FDA UDI
- Generic Name
- Arm splint system, self-moulding FDA UDI
- Device Name
- Medical polymer splint EUDAMED
- Model / Reference
- 312；7.5cm×30cm EUDAMED- EUDAMED7.5cm×30cm FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06971642800034 EUDAMEDFDA UDI
- Basic UDI-DI
- 697164280MPSM03050202BD EUDAMED
- FDA Product Code
- HSP FDA UDI
- EMDN Code
- M03050202 SYNTHETIC CAST BANDAGES AND SPLINTS EUDAMED
- GMDN Term
- Arm splint system, self-moulding FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 888.5890 FDA UDI
- Market of Registration
- Norway 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
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Arm splint system, self-moulding
Rtmed by Shandong Haidike Medical Products Co., Ltd. — Class I — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Arm splint system, self-moulding.
- ActiSplint with Sensi-Wrap — Dynarex Corp. · Class I
- RTMED — Shandong Haidike Medical Products Co., Ltd. · Class I
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class I | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Shandong Haidike Medical Products Co., Ltd.
Sources (2)
- FDA UDI 488cf1b2-0b33-4a7c-97a0-19484208cd21 32 fields · synced Jul 26, 2026
- EUDAMED a7231a85-8cf2-45f3-b426-7372813287ac 61 fields · synced Jul 26, 2026