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Thermoplastic Splint
EUDAMEDClass I (EU MDR)
Ref NEW YOGIPS - HSL600MiniRef POCKET YOGIPS - ULL700Ref POCKET YOGIPS - ULL777Ref NEW YOGIPS PLUS - PSA410Ref NEW YOGIPS - HSA300DorsalRef POCKET YOGIPS - ULA550Ref NEW YOGIPS PLUS - PFS1000Ref NEW YOGIPS PLUS - PLA550Ref POCKET YOGIPS - USA410ARef NEW YOGIPS PLUS - PSA300UlnarRef NEW YOGIPS PLUS - PSA420Ref NEW YOGIPS PLUS - PSA220Ref NEW YOGIPS PLUS - PSADorsalRef POCKET YOGIPS - USA410BRef POCKET YOGIPS - USA1000Ref POCKET YOGIPS - ULA500Ref NEW YOGIPS - HLL740Ref NEW YOGIPS - HLL700Ref NEW YOGIPS - HSA300UlnarRef POCKET YOGIPS - YLL750Ref NEW YOGIPS - HFS1000Ref POCKET YOGIPSRef POCKET YOGIPS - USL640Ref POCKET YOGIPS - USA220Ref NEW YOGIPS - HSL600Ref NEW YOGIPS PLUS - PSL600MiniRef POCKET YOGIPS - USA300V
Identity
- Device Name
- THERMOPLASTIC SPLINT EUDAMED
- Model / Reference
- NEW YOGIPS - HSL600Mini EUDAMEDPOCKET YOGIPS - ULL700 EUDAMEDPOCKET YOGIPS - ULL777 EUDAMEDNEW YOGIPS PLUS - PSA410 EUDAMEDNEW YOGIPS - HSA300Dorsal EUDAMEDPOCKET YOGIPS - ULA550 EUDAMEDNEW YOGIPS PLUS - PFS1000 EUDAMEDNEW YOGIPS PLUS - PLA550 EUDAMEDPOCKET YOGIPS - USA410A EUDAMEDNEW YOGIPS PLUS - PSA300Ulnar EUDAMEDNEW YOGIPS PLUS - PSA420 EUDAMEDNEW YOGIPS PLUS - PSA220 EUDAMEDNEW YOGIPS PLUS - PSADorsal EUDAMEDPOCKET YOGIPS - USA410B EUDAMEDPOCKET YOGIPS - USA1000 EUDAMEDPOCKET YOGIPS - ULA500 EUDAMEDNEW YOGIPS - HLL740 EUDAMEDNEW YOGIPS - HLL700 EUDAMEDNEW YOGIPS - HSA300Ulnar EUDAMEDPOCKET YOGIPS - YLL750 EUDAMEDNEW YOGIPS - HFS1000 EUDAMEDPOCKET YOGIPS EUDAMEDPOCKET YOGIPS - USL640 EUDAMEDPOCKET YOGIPS - USA220 EUDAMEDNEW YOGIPS - HSL600 EUDAMEDNEW YOGIPS PLUS - PSL600Mini EUDAMEDPOCKET YOGIPS - USA300V EUDAMED
Identifiers
- Primary DI / UDI-DI
- 138800211HSL600Mini097 EUDAMED138800211ULL700048 EUDAMED138800211ULL777054 EUDAMED138800211PSA410062 EUDAMED138800211HSA300Dorsal098 EUDAMED138800211ULA550095 EUDAMED138800211PFS1000036 EUDAMED138800211PLA550015 EUDAMED138800211USA410A033 EUDAMED138800211PSA300Ulnar030 EUDAMED138800211PSA420059 EUDAMED138800211PSA220022 EUDAMED138800211PSADorsal003 EUDAMED138800211USA410B023 EUDAMED138800211USA1000013 EUDAMED138800211ULA500013 EUDAMED138800211HLL740022 EUDAMED138800211HLL700034 EUDAMED138800211HSA300Ulnar063 EUDAMED138800211YLL750097 EUDAMED138800211HFS1000017 EUDAMED138800211USL600083 EUDAMED138800211USL640071 EUDAMED138800211USA220005 EUDAMED138800211HSL600069 EUDAMED138800211PSL600Mini086 EUDAMED138800211USA300V019 EUDAMED
- Basic UDI-DI
- 88002111EUTHLJ EUDAMED
- Direct Marketing DI
- 138800211HSL600Mini097 EUDAMED138800211ULL700048 EUDAMED138800211ULL777054 EUDAMED138800211PSA410062 EUDAMED138800211HSA300Dorsal098 EUDAMED138800211ULA550095 EUDAMED138800211PFS1000036 EUDAMED138800211PLA550015 EUDAMED138800211USA410A033 EUDAMED138800211PSA300Ulnar030 EUDAMED138800211PSA420059 EUDAMED138800211PSA220022 EUDAMED138800211PSADorsal003 EUDAMED138800211USA410B023 EUDAMED138800211USA1000013 EUDAMED138800211ULA500013 EUDAMED138800211HLL740022 EUDAMED138800211HLL700034 EUDAMED138800211HSA300Ulnar063 EUDAMED138800211YLL750097 EUDAMED138800211HFS1000017 EUDAMED138800211USL600083 EUDAMED138800211USL640071 EUDAMED138800211USA220005 EUDAMED138800211HSL600069 EUDAMED138800211PSL600Mini086 EUDAMED138800211USA300V019 EUDAMED
- EMDN Code
- Y061299 LOWER EXTREMITY ORTHOSES - OTHER EUDAMEDY060699 ORTHOSES, UPPER EXTREMITY - OTHER EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- France 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
Thermoplastic Splint by Woosam Medical Co., Ltd. — 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 | 88002111EUTHLJ | Class I | Active |
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Manufacturer
- Manufacturer
- Woosam Medical Co., Ltd.
- EUDAMED SRN
- KR-MF-000045208
- Authorised Representative
- AF Pharma Service Europe SL ES-AR-000018076
Sources (27)
- EUDAMED 1711f491-f5cd-4e94-98b4-441939bc7e51 61 fields · synced Aug 1, 2026
- EUDAMED 18f75916-b07a-4259-b02a-a314c52381dd 61 fields · synced May 11, 2026
- EUDAMED 6873a654-26f5-482b-856b-06cd1b396bfc 61 fields · synced May 16, 2026
- EUDAMED 64d046ca-fdf7-406f-afaa-e0b88a31e403 61 fields · synced May 16, 2026
- EUDAMED afcdb187-c9a1-4050-bc29-8b8e8dd8572e 61 fields · synced May 16, 2026
- EUDAMED 7a319457-433b-45b3-96a5-a1568d9bcfc6 61 fields · synced May 16, 2026
- EUDAMED 2964aeca-481b-4cbe-ad5c-b536bf1f5824 61 fields · synced May 16, 2026
- EUDAMED a99c2c44-9d39-49f1-9e8f-eac777dc4067 61 fields · synced May 17, 2026
- EUDAMED 60e4b68c-53d5-47fd-884f-8a1bea3c0d98 61 fields · synced May 17, 2026
- EUDAMED 13aedf2b-2372-46ea-9599-bb1aa0aeb203 61 fields · synced May 17, 2026
- EUDAMED 29293a9b-f0c6-4de2-9329-92c21fcd7854 61 fields · synced May 17, 2026
- EUDAMED 638e5da7-303e-4adb-b2a0-f605ee08c410 61 fields · synced May 17, 2026
- EUDAMED 03c0b77a-a175-41d7-aade-4fb1ce57831e 61 fields · synced May 17, 2026
- EUDAMED 5e7f384d-2125-42ed-acb6-eed806710eb2 61 fields · synced May 17, 2026
- EUDAMED 3d94d2b0-27a4-4ba6-8e28-e4e3bdb4b3be 61 fields · synced May 17, 2026
- EUDAMED 2af579a4-f195-4a83-bfc8-a9c20ae9ca85 61 fields · synced May 17, 2026
- EUDAMED e27088be-d1f1-44b7-afb1-2ffcfad5f98d 61 fields · synced May 18, 2026
- EUDAMED 48ba9b32-3250-4eb9-bd41-d6ba8e38294a 61 fields · synced May 18, 2026
- EUDAMED cdc7fed2-b509-431b-82c5-87a3db179d57 61 fields · synced May 18, 2026
- EUDAMED 31701cb4-a9a6-4015-a975-600d42cd95ca 61 fields · synced May 18, 2026
- EUDAMED ed01243c-57a6-4b70-904f-e9557638a083 61 fields · synced May 18, 2026
- EUDAMED 954fd37e-11ba-4793-a04e-d7414495a180 61 fields · synced May 18, 2026
- EUDAMED cc06ec7e-425b-40fa-98ed-505c1f0d3495 61 fields · synced May 19, 2026
- EUDAMED 0d348f11-045d-42a1-8f30-0582c6fca7d9 61 fields · synced May 19, 2026
- EUDAMED 618329ef-9dd7-4e4c-8d60-08edaa533dde 61 fields · synced May 19, 2026
- EUDAMED 4d186e9c-0029-426b-a6b5-ac2a1e42d039 61 fields · synced May 19, 2026
- EUDAMED a078931f-1e84-4393-9aa8-870438a8a028 61 fields · synced May 19, 2026