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Dr. Frei KIDS
EUDAMEDClass I (EU MDR)
Ref KD 814 - MModel KD 814Ref KD 910 - MModel KD 910Ref KD 910 - LRef KD 205 - MModel KD 205Ref KD 205 - LRef KD 852 - MModel KD 852Ref KD 852 - LRef KD 710
Identity
- Trade Name
- Dr. Frei KIDS EUDAMED
- Device Name
- Child thumb splint EUDAMEDChild arm sling EUDAMEDChild reclinator (posture support) EUDAMEDChild wrist splint with stay EUDAMEDChild ankle support EUDAMED
- Model / Reference
- KD 814 EUDAMEDKD 814 - M EUDAMEDKD 910 EUDAMEDKD 910 - M EUDAMEDKD 910 - L EUDAMEDKD 205 EUDAMEDKD 205 - M EUDAMEDKD 205 - L EUDAMEDKD 852 EUDAMEDKD 852 - M EUDAMEDKD 852 - L EUDAMEDKD 710 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 03800232484961 EUDAMED03800232485012 EUDAMED03800232485029 EUDAMED03800232484916 EUDAMED03800232484923 EUDAMED03800232484985 EUDAMED03800232484992 EUDAMED03800232484954 EUDAMED
- Basic UDI-DI
- 3800232484961TN EUDAMED3800232485005S6 EUDAMED3800232484916TH EUDAMED3800232484985U4 EUDAMED3800232484954TR EUDAMED
- EMDN Code
- M03050299 BANDAGES AND SPLINTS - OTHER EUDAMEDM030501 IMMOBILISATION BANDAGES FOR SHOULDER, ARM AND COLLARBONE EUDAMEDM03040299 ELASTIC SUPPORT BANDAGES - OTHER EUDAMEDM0399 BANDAGES - OTHER (see Y06 for collars, tutors, etc.) EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Bulgaria EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
Yes
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
Category: Hand/finger splint, reusable
Dr. Frei KIDS by Medtex Swiss Ltd — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Hand/finger splint, reusable.
- Elastic Bandage — Anji Xinyuan Medical Supplies Co.,Ltd. · Class I
- Plastalume — BROWNMED, INC. · Class I
- Splint — Anping Guardian Medical Equipment Co., Ltd · Class I
- ORTHOSIS FRACTURE WRIST-HAND PLASTICAST — AliMed, LLC · Class I
- PERFORMANCE HEALTH — Asp Global, LLC · Class I
- McKie Thumb Splint Pediatric — McKie Splints, LLC · Class I
- Plastalume — BROWNMED, INC. · Class I
- McKie Thumb Splint Adult — McKie Splints, LLC · Class I
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 | 3800232484961TN | Class I | Active |
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Manufacturer
- Manufacturer
- Medtex Swiss Ltd
- EUDAMED SRN
- BG-MF-000023453
Sources (8)
- EUDAMED ae93418a-3aa8-42df-b9dc-63860158be45 61 fields · synced Aug 4, 2026
- EUDAMED 7c887a37-08f9-4cdf-9729-a92f8b05827e 61 fields · synced May 16, 2026
- EUDAMED c2846dc0-5702-4e98-8f2d-d57c5cacdb8d 61 fields · synced May 16, 2026
- EUDAMED 23995e23-92ac-4d0e-8a64-6e29d307573c 61 fields · synced May 17, 2026
- EUDAMED 494174c0-29cb-45a6-9d0a-ebe3b3eda860 61 fields · synced May 17, 2026
- EUDAMED 659c4a86-d430-40a6-8b15-9efc0a2bfe0c 61 fields · synced May 17, 2026
- EUDAMED 5a9a8ce0-80a0-4d1b-9ea0-3d9654afbd78 61 fields · synced May 18, 2026
- EUDAMED 8173138e-197d-456e-906c-6cda6fa7651a 61 fields · synced May 18, 2026