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SAM® Splint
EUDAMEDFDA UDIClass I (EU MDR)
Ref SP502-CH-ENRef SP507-OB-ENRef SP506-OB-DERef SP502-OB-DERef SP502-OB-EN
Identity
- Trade Name
- SAM® Splint EUDAMEDSAM® Splint [EN] EUDAMEDSAM Splint FDA UDI
- Generic Name
- First aid limb splint, mouldable, reusable FDA UDI
- Device Name
- SAM® Splint EUDAMEDSAM JUNIOR SPLINT 18IN FLAT ORANGE/BLUE FDA UDISAM SPLINT 36IN FLAT ORANGE/BLUE FDA UDISAM JUNIOR SPLINT 18IN FLAT CHARCOAL FDA UDI
- Model / Reference
- SP502-CH-EN EUDAMEDFDA UDISP507-OB-EN EUDAMEDFDA UDISP506-OB-DE EUDAMEDSP502-OB-DE EUDAMEDSP502-OB-EN EUDAMEDFDA UDI
- Description
- SAM JUNIOR SPLINT 18IN FLAT ORANGE/BLUE FDA UDISAM SPLINT 36IN FLAT ORANGE/BLUE FDA UDISAM JUNIOR SPLINT 18IN FLAT CHARCOAL FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00822045428928 EUDAMEDFDA UDI00822045428676 EUDAMEDFDA UDI00822045001053 EUDAMED00822045000988 EUDAMED00822045428713 EUDAMEDFDA UDI
- Basic UDI-DI
- 0822045SP01US EUDAMED
- FDA Product Code
- NOC FDA UDI
- EMDN Code
- M03050202 SYNTHETIC CAST BANDAGES AND SPLINTS EUDAMED
- GMDN Term
- First aid limb splint, mouldable, reusable FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 878.3910 FDA UDI
- Market of Registration
- Netherlands EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
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
Yes
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
No
FDA UDI
Manufacturing Date
No
FDA UDI
MR Conditional FDA UDI
Category: Cotton wool roll, sterile
SAM® Splint by SAM Medical Products — 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 | 0822045SP01US | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- SAM Medical Products
- EUDAMED SRN
- US-MF-000002589
- Authorised Representative
- Emergo Europe B.V. NL-AR-000000116
Sources (11)
- EUDAMED d2c9e140-8203-44e1-93b0-41a7ceea8a7c 61 fields · synced Aug 2, 2026
- EUDAMED 811916d4-339a-4b26-baab-21d38984e490 61 fields · synced May 16, 2026
- EUDAMED 8fa52185-599a-4af2-82c1-7b7de854c6e3 61 fields · synced May 18, 2026
- EUDAMED 4cdb0992-ea81-470d-8583-d99a98af1ea6 61 fields · synced May 18, 2026
- EUDAMED a27ffa19-5296-4402-9c55-061962879587 61 fields · synced May 18, 2026
- FDA UDI f6b3457d-83ea-464b-8a65-a712c1997fee 34 fields · synced May 30, 2026
- FDA UDI 26b9ba8d-64fa-46e7-a5dc-a8a3fd49624a 34 fields · synced May 30, 2026
- FDA UDI a445b52c-9fef-4f8a-becd-db0eeabaee4e 34 fields · synced May 30, 2026
- EUDAMED 296d8513-0abe-4d69-9c37-ec011f94b837 61 fields · synced Jul 25, 2026
- EUDAMED b1603baf-a181-45d5-8074-c75e4d5d2194 61 fields · synced Jul 27, 2026
- EUDAMED 69bbf446-e492-47c4-87aa-889acd8ba127 61 fields · synced Aug 2, 2026