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Scott Specialties
EUDAMEDClass I (EU MDR)
Ref 1214PRI2XModel 1214PRISMRef 1214PRIXLRef 0118BLAXLRef 1214PRILG
Identity
- Trade Name
- Scott Specialties EUDAMED
- Device Name
- PEDIATRIC ARM SLING SMALL EUDAMEDHERNIA BELT EUDAMED
- Model / Reference
- 1214PRISM EUDAMED1214PRI2X EUDAMED1214PRIXL EUDAMED0118BLAXL EUDAMED1214PRILG EUDAMED
Identifiers
- Primary DI / UDI-DI
- 07631897264508 EUDAMED07631897264430 EUDAMED0763189723695 EUDAMED07631890102760 EUDAMED
- Basic UDI-DI
- 7631891214AT EUDAMED7631890118AP EUDAMED
- EMDN Code
- Y060624 SHOULDER-ELBOW ORTHOSES EUDAMEDY060406 ABDOMINAL HERNIA SUPPORTS EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Netherlands 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
Scott Specialties by Elastic Therapy — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
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 | 7631891214AT | Class I | Active |
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Manufacturer
- Manufacturer
- Elastic Therapy
- EUDAMED SRN
- US-MF-000021563
- Authorised Representative
- CEpartner4U NL-AR-000000111
Sources (4)
- EUDAMED e13677ae-a9b4-4e47-a8d2-c9ce93ac316f 61 fields · synced Jul 30, 2026
- EUDAMED 0bd591cc-7497-4b15-b836-873ac5336123 61 fields · synced May 18, 2026
- EUDAMED 7b2fdf7b-720d-4279-9272-54e47dfb246e 61 fields · synced May 18, 2026
- EUDAMED 78ff62b5-04c9-4b5e-8d95-0a2999513864 61 fields · synced May 18, 2026