Fabricant

Tehlin

TaïwanEntités : Teh Lin Prosthetic & Orthopaedic lnc

Marchés : Allemagne

Autorisations : UE – classe I

Mandataire UE : MedNet EC-REP GmbH (Allemagne)

service.global@tehlin.com

9 catégories, 150 modèles dont 150 en vente, 1 pays

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93/42 Ancienne directive, pas encore certifié selon le règlement MDR
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Catégorie	Code EMDN	Modèles enregistrés	Classe	Contact
Transradial prostheses (for amputation under elbow)	Y061809	2 Degrees of flexion wrist BE control kit J-HT-106 BE harness Female cosmetic silicone glove J-TL-72101L Female cosmetic silicone glove J-TL-72101R 36 autres Female cosmetic silicone glove J-TL-72102L Female cosmetic silicone glove J-TL-72102R Female cosmetic silicone glove J-TL-72103L Female cosmetic silicone glove J-TL-72103R Female cosmetic silicone glove J-TL-72104L Female cosmetic silicone glove J-TL-72104R Female functional silicone glove J-TL-72203L Female functional silicone glove, Male functional silicone glove J-TL-72203R2 réf. Foam palm (No.1/Left) Foam palm (No.1/Right) Foam palm (No.2/Left) Foam palm (No.2/Right) Foam palm (No.3/Left) Foam palm (No.3/Right) Foam palm (No.4/Left) Foam palm (No.4/Right) Foam palm (No.5/Left) Foam palm (No.5/Right) Foam palm (No.6/Left) Foam palm (No.6/Right) Functional hook (Left), (Right) J-HT-12RTL2 réf. Functional palm ( (Right/Large) Functional palm (Left/Large) Functional palm (Left/Small) Functional palm (Right/Small) Male cosmetic silicone glove J-TL-82101L Male cosmetic silicone glove J-TL-82101R Male cosmetic silicone glove J-TL-82102L Male cosmetic silicone glove J-TL-82102R Male cosmetic silicone glove J-TL-82103L Male cosmetic silicone glove J-TL-82103R Male functional silicone glove J-TL-82204R Quick change wrist Rotator6 réf. Wrist (Large) J-HT-010L Wrist (Small) J-HT-010S	I MDR	Fiche EUDAMED Signaler une erreur
Transfemoral prostheses (for amputation above knee)	Y062415	ADLIB 2 Microprocessor 5 Bar Pneumatic Knee Prosthesis2 réf. ADLIB 2 Microprocessor 5 Bar Pneumatic Knee Prosthesis with Pyramid Connector GRAPH-LITE 4 BAR KNEE GRAPH-LITE 4 BAR KNEE WITH 30° MANUAL LOCK GRAPH-LITE 4 BAR KNEE WITH MANUAL LOCK 26 autres GRAPH-LITE 4 BAR PNEUMATIC KNEE GRAPH-LITE 4 BAR PNEUMATIC KNEE (MINI) GRAPH-LITE 4 BAR PNEUMATIC KNEE - DISARTICULATION KNEE Graph-lite 5 Bar Knee Graph-lite 5 Bar Pneumatic Knee High Activity Graph-lite 5 Bar Pneumatic Knee-Disarticulation Knee HY-STAN 4 BAR KNEE DISARTICULATION KNEE HY-STAN 4 BAR KNEE WITH MANUAL LOCK HY-STAN 4 BAR KNEE, Secure Stride G, Secure Stride M3 réf. HY-STAN 4 BAR PNEUMATIC KNEE HY-STAN 4 BAR PNEUMATIC KNEE (MINI) HY-STAN 4-BAR KNEE WITH 30° MANUAL LOCK Hy-Stan Child’s 4 Bar Knee Hy-Stan Single Axis Child’s Knee With Manual Lock MECHANICAL 4-BAR KNEE JOINT Mini 4 Bar Child’s Pneumatic Knee2 réf. PHOENIX GRAPH-LITE 4 BAR PNEUMATIC KNEE RAYOME 4 BAR HYDRAULIC KNEE RAYOME 4 BAR PNEUMATIC KNEE Secure Stride GP Secure Stride SF Shoulder joint V One Microprocessor Four-Bar Pneumatic Knee Prosthesis with Pyramid Connector V One Net Microprocessor Four-Bar Pneumatic Knee Prosthesis2 réf. XTREME X60 4-BAR HYDRAULIC KNEE JOINT2 réf. XTREME X60 HYDRAULIC KNEE	I MDR	Fiche EUDAMED Signaler une erreur
Transhumeral prostheses (for amputation above elbow)	Y061815	AE control kit AE harness (Left) AE harness (Right) AE short stump lifter (Left) AE short stump lifter (Right) 16 autres AK ribbed cosmetic stocking 30” AK ribbed cosmetic stocking 35” , AK ribbed cosmetic stocking 38”2 réf. AK ribbed cosmetic stocking 41” AK sheer cosmetic stocking 30” AK sheer cosmetic stocking 35” AK sheer cosmetic stocking 38” AK sheer cosmetic stocking 41” Cosmetic arm kit J-HT-008 Elbow joint (Large) Elbow joint (Small) Elbow joint for cosmetic hand Hand foam cover H-TFC-AE Locking hinge Medial locking (Left) Medial locking (Right) Upper arm protection slice	I MDR	Fiche EUDAMED Signaler une erreur
Foot partial prostheses (including toe prostheses)	Y062403	Adjustable multi-axis ankle joint (60°) Adjustable multi-axis ankle joint (70°) Adjustable multi-axis ankle joint (80°) Child's ankle2 réf. Graph-lite fixed SACH ankle with bolt 12 autres Graph-lite multi-axis ankle Graph-lite ultra-short ankle Hy-stan fixed SACH ankle with bolt Hy-stan single axis ankle Hy-stan ultra-short ankle Hy-stan ultra-short flat ankle joint (60°) Hy-stan ultra-short flat ankle joint (70°) Hy-stan ultra-short flat ankle joint (80°) Pipe connection multi-axis ankle joint (60°) Pipe connection multi-axis ankle joint (70°) Pipe connection multi-axis ankle joint (80°) SACH foot adapter FA156	I MDR	Fiche EUDAMED Signaler une erreur
Lower extremity prostheses - other	Y062499	10” Hy-Stan tube 12” Graph-lite tube 12”Child's tube 14” Hy-Stan tube 15”Child's tube 8 autres 17” Hy-Stan tube Adjustable pyramid adaptor Adjustable pyramid adaptor/Translatable Pyramid Adapter, Titanium/Pyramid Adapter, Titanium3 réf. Graph-lite fixed adaptor with pylon & 4 screws Hy-Stan fixed adaptor with 8” tube (central hole threaded) Knee rotator Transfemoral rotator Tube clamp adapter (stainless steel) FA153	I MDR	Fiche EUDAMED Signaler une erreur
Aesthetic fillers, calf and thigh	Y062703	BK Exoskeletal Foam Cover2 réf. Child's Eva-Last Cosmetic Cover, Extra Small/Left Child's Eva-Last Cosmetic Cover, Extra Small/Right Child's Exoskeletal Foam Cover EVA-Foam Sheet -soft, EVA Foam Sheet 100cm x 200cm (12mm thickness)2 réf. 6 autres Eva-Last Cosmetic Cover, Large/Left Eva-Last Cosmetic Cover, Large/Right Eva-Last Cosmetic Cover, Medium/Left Eva-Last Cosmetic Cover, Medium/Right Eva-Last Cosmetic Cover, Small/Left Eva-Last Cosmetic Cover, Small/Short	I MDR	Fiche EUDAMED Signaler une erreur
Hip disarticulation prostheses	Y062418	Child's lamination plate (aluminum) Child's lamination plate (stainless steel) Child’s Hy-Stan Hip Joint / Red Graph-Lite Hip Joint Hy-Stan Hip Joint 2 autres Lamination plate (aluminum) Lamination plate (stainless steel)	I MDR	Fiche EUDAMED Signaler une erreur
Transtibial prostheses (for amputation under knee)	Y062409	CHILD'S SACH FOOT WITH TOES3 réf. FLAT SACH FOOT WITH TOES F-TSF-0122L3 réf. Kare dynamic foot with ankle (22L), (22R), (23L), (23R), (24L), (24R), (25L), (25R), (26L), (26R), (27L), (27R), (28L), (28R)3 réf. SACH FOOT WITH SPLIT TOES3 réf. SINGLE AXIS FLAT FOOT WITH TOES3 réf. 1 autre SINGLE AXIS FOOT WITH TOES (18mm)-22L, 22R, 23L, 23R, 24L, 24R, 25L, 25R, 26L, 26R, 27L, 27R, 28L, 28R, 29L, 29R, 30L, 30R3 réf.	I MDR	Fiche EUDAMED Signaler une erreur
Knee disarticulation prostheses	Y062412	Child's L-bracket, aluminum with extensions Child's L-bracket, steel with extensions L-bracket, aluminum with extensions	I MDR	Fiche EUDAMED Signaler une erreur

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