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Surestep

EUDAMED

Class I (EU MDR)

Ref SSSNBL11.0WYModel SSSNBLRef 1960-SSA-SSRef SSSNPU06.0WTModel SSSNPURef 1902-SMO-05TLRef 1902-SMO-08TRef 1902-SMO-06TRRef 1902-SMO-03TRRef SSSNPK11.0WYModel SSSNPKRef SSSNBK6.0WTModel SSSNBKRef 1846-HK2-SSRef SSSNPK6.0WTRef 1845-XL-LAV-LTRef SSSNGO01.0WYModel SSSNGORef SSSNPU08.0WTRef SSDEROTATION-ADU-CUSTOMRef SSSNPU12.0WYRef 1846-HK1-SSRef SSDEROTATION-PEDBKRef SSSNGO05.0WTRef 1902-SMO-06TLRef SSSNGO02.0WYRef SSSNBK4.0WTRef SSSNBL6.0WTRef SSSNBL12.0WYRef SSSNBG06.0WTModel SSSNBGRef 1902-SMO-06TRef SSSNGR03.0WYModel SSSNGRRef SSSNGR06.0WTRef 1902-SMO-03TLRef SSSNPU05.0WTRef 1845-MD-BLK-LTRef SSSNPK3.0WTRef 1902-SMO-11YLRef 1902-SMO-10YRRef SSSNPU07.0WTRef SSSNBL9.0WTRef SSSNBG07.0WTRef 1902-SMO-04TRRef SSSNBG01.0WYRef SSSNGR01.0WYRef 1845-MD-LAV-RTRef 1902-SMO-10yRef SSSNGO11.0WYRef 1845-SM-BLK-RTRef SSSNBK3.0WTRef SSSNPU03.0WYRef SSSNBL7.0WTRef 1902-SMO-09TRef 1902-SMO-05TRRef 1902-SMO-09TLRef SSSNBL3.0WTRef SSSNGR08.0WTRef 1970-I2S-SSRef 1960-I2S-SSRef 1845-XL-LAV-RTRef 1902-SMO-10YLRef SSSNGR05.0WTRef 1845-SM-LAV-LTRef SSSNBG03.0WYRef 1845-LG-BLK-RTRef 1902-SMO-04TLRef SSSNBG13.0WYRef 1845-LG-BLK-LTRef SSSNBL5.0WTRef SSSNPK12.0WYRef SSSNBK7.0WTRef SSSNBL10.0WYRef 1499-DCO-INFRef SSSNBK12.0WYRef SSSNGR07.0WTRef 1902-SMO-11yRef SSSNGR04.0WTRef 1902-SMO-08TRRef 1902-SMO-12YRRef 1845-LG-LAV-LTRef SSSNPK7.0WTRef SSSNGO03.0WTRef SSSNGR13.0WYRef SSDEROTATION-ADUWTRef SSDEROTATION-PEDBGRef SSSNBK10.0WYRef SSSNGO09.0WTRef SSSNBK11.0WYRef SSSNPU03.0WTRef SSSNPK4.0WTRef 1845-LG-LAV-RTRef SSSNBL4.0WTRef 1499-DCO-ADURef 1907-SMO-SSRef 1845-SM-LAV-RTRef SSSNPU13.0WY

by Surestep, LLC

Identity

Trade Name
Surestep EUDAMED
Device Name
Surestep Sneakers Blue EUDAMED
SureStep Advanced AFO EUDAMED
Surestep Sneakers - Purple EUDAMED
Surestep GO! Series SMO EUDAMED
Surestep Sneakers - Pink EUDAMED
Surestep Sneakers - Black EUDAMED
SureStep HEKO - Molded EUDAMED
SureStep HEKO - Prefabricated EUDAMED
Surestep Sneakers - Gold EUDAMED
Suretep Derotation Straps EUDAMED
Surestep Sneakers - Black/Gray Suede EUDAMED
Surestep Sneakers - Green EUDAMED
1970-I2S-SS EUDAMED
SureStep Indy 2 Stage - Solid Ankle EUDAMED
SureStep Dynamic Cervical Orthosis - Prefabricated EUDAMED
SureStep SMO EUDAMED
Model / Reference
SSSNBL EUDAMED
SSSNBL11.0WY EUDAMED
1960-SSA-SS EUDAMED
SSSNPU EUDAMED
SSSNPU06.0WT EUDAMED
1902-SMO-05TL EUDAMED
1902-SMO-08T EUDAMED
1902-SMO-06TR EUDAMED
1902-SMO-03TR EUDAMED
SSSNPK EUDAMED
SSSNPK11.0WY EUDAMED
SSSNBK EUDAMED
SSSNBK6.0WT EUDAMED
1846-HK2-SS EUDAMED
SSSNPK6.0WT EUDAMED
1845-XL-LAV-LT EUDAMED
SSSNGO EUDAMED
SSSNGO01.0WY EUDAMED
SSSNPU08.0WT EUDAMED
SSDEROTATION-ADU-CUSTOM EUDAMED
SSSNPU12.0WY EUDAMED
1846-HK1-SS EUDAMED
SSDEROTATION-PEDBK EUDAMED
SSSNGO05.0WT EUDAMED
1902-SMO-06TL EUDAMED
SSSNGO02.0WY EUDAMED
SSSNBK4.0WT EUDAMED
SSSNBL6.0WT EUDAMED
SSSNBL12.0WY EUDAMED
SSSNBG EUDAMED
SSSNBG06.0WT EUDAMED
1902-SMO-06T EUDAMED
SSSNGR EUDAMED
SSSNGR03.0WY EUDAMED
SSSNGR06.0WT EUDAMED
1902-SMO-03TL EUDAMED
SSSNPU05.0WT EUDAMED
1845-MD-BLK-LT EUDAMED
SSSNPK3.0WT EUDAMED
1902-SMO-11YL EUDAMED
1902-SMO-10YR EUDAMED
SSSNPU07.0WT EUDAMED
SSSNBL9.0WT EUDAMED
SSSNBG07.0WT EUDAMED
1902-SMO-04TR EUDAMED
SSSNBG01.0WY EUDAMED
SSSNGR01.0WY EUDAMED
1845-MD-LAV-RT EUDAMED
1902-SMO-10y EUDAMED
SSSNGO11.0WY EUDAMED
1845-SM-BLK-RT EUDAMED
SSSNBK3.0WT EUDAMED
SSSNPU03.0WY EUDAMED
SSSNBL7.0WT EUDAMED
1902-SMO-09T EUDAMED
1902-SMO-05TR EUDAMED
1902-SMO-09TL EUDAMED
SSSNBL3.0WT EUDAMED
SSSNGR08.0WT EUDAMED
1970-I2S-SS EUDAMED
1960-I2S-SS EUDAMED
1845-XL-LAV-RT EUDAMED
1902-SMO-10YL EUDAMED
SSSNGR05.0WT EUDAMED
1845-SM-LAV-LT EUDAMED
SSSNBG03.0WY EUDAMED
1845-LG-BLK-RT EUDAMED
1902-SMO-04TL EUDAMED
SSSNBG13.0WY EUDAMED
1845-LG-BLK-LT EUDAMED
SSSNBL5.0WT EUDAMED
SSSNPK12.0WY EUDAMED
SSSNBK7.0WT EUDAMED
SSSNBL10.0WY EUDAMED
1499-DCO-INF EUDAMED
SSSNBK12.0WY EUDAMED
SSSNGR07.0WT EUDAMED
1902-SMO-11y EUDAMED
SSSNGR04.0WT EUDAMED
1902-SMO-08TR EUDAMED
1902-SMO-12YR EUDAMED
1845-LG-LAV-LT EUDAMED
SSSNPK7.0WT EUDAMED
SSSNGO03.0WT EUDAMED
SSSNGR13.0WY EUDAMED
SSDEROTATION-ADUWT EUDAMED
SSDEROTATION-PEDBG EUDAMED
SSSNBK10.0WY EUDAMED
SSSNGO09.0WT EUDAMED
SSSNBK11.0WY EUDAMED
SSSNPU03.0WT EUDAMED
SSSNPK4.0WT EUDAMED
1845-LG-LAV-RT EUDAMED
SSSNBL4.0WT EUDAMED
1499-DCO-ADU EUDAMED
1907-SMO-SS EUDAMED
1845-SM-LAV-RT EUDAMED
SSSNPU13.0WY EUDAMED

Identifiers

Primary DI / UDI-DI
00810080700383 EUDAMED
00810080701106 EUDAMED
00810080700918 EUDAMED
00810080701540 EUDAMED
00810080701007 EUDAMED
00810080701557 EUDAMED
00810080701496 EUDAMED
00810080700550 EUDAMED
00810080700604 EUDAMED
00810080701137 EUDAMED
00810080700505 EUDAMED
00810080701298 EUDAMED
00810080700741 EUDAMED
00810080700932 EUDAMED
00810080701250 EUDAMED
00810080701687 EUDAMED
00810080701120 EUDAMED
00810080701212 EUDAMED
00810080701724 EUDAMED
00810080701564 EUDAMED
00810080700758 EUDAMED
00810080700581 EUDAMED
00810080700437 EUDAMED
00810080700390 EUDAMED
00810080701809 EUDAMED
00810080700987 EUDAMED
00810080701861 EUDAMED
00810080700840 EUDAMED
00810080701502 EUDAMED
00810080700901 EUDAMED
00810080701359 EUDAMED
00810080700475 EUDAMED
00810080701465 EUDAMED
00810080701427 EUDAMED
00810080700925 EUDAMED
00810080700468 EUDAMED
00810080701816 EUDAMED
00810080701519 EUDAMED
00810080700673 EUDAMED
00810080701847 EUDAMED
00810080701311 EUDAMED
00810080701021 EUDAMED
00810080700789 EUDAMED
00810080701403 EUDAMED
00810080700574 EUDAMED
00810080701656 EUDAMED
00810080700444 EUDAMED
00810080701014 EUDAMED
00810080701533 EUDAMED
00810080701625 EUDAMED
00810080700406 EUDAMED
00810080700864 EUDAMED
00810080701090 EUDAMED
00810080701083 EUDAMED
00810080701335 EUDAMED
00810080701434 EUDAMED
00810080700833 EUDAMED
00810080701281 EUDAMED
00810080700697 EUDAMED
00810080701380 EUDAMED
00810080701526 EUDAMED
00810080700734 EUDAMED
00810080701342 EUDAMED
00810080700420 EUDAMED
00810080700567 EUDAMED
00810080700611 EUDAMED
00810080700376 EUDAMED
00810080701168 EUDAMED
00810080700666 EUDAMED
00810080700857 EUDAMED
00810080701038 EUDAMED
00810080700826 EUDAMED
00810080701595 EUDAMED
00810080701472 EUDAMED
00810080701267 EUDAMED
00810080700512 EUDAMED
00810080701700 EUDAMED
00810080701908 EUDAMED
00810080701236 EUDAMED
00810080701229 EUDAMED
00810080700642 EUDAMED
00810080701762 EUDAMED
00810080700659 EUDAMED
00810080700888 EUDAMED
00810080700482 EUDAMED
00810080701304 EUDAMED
00810080700413 EUDAMED
00810080701182 EUDAMED
00810080701052 EUDAMED
00810080701328 EUDAMED
00810080701694 EUDAMED
Basic UDI-DI
0081008070SSSNBLVK EUDAMED
0810080701960-SSA-SSTM EUDAMED
0081008070SSSNPUXF EUDAMED
00810080701902-SMOTR EUDAMED
0081008070SSSNPKWT EUDAMED
0081008070SSSNBKVH EUDAMED
00810080701846-HKQZ EUDAMED
008100807018458J EUDAMED
0081008070SSSNGOW8 EUDAMED
0081008070SSDEROT4C EUDAMED
0081008070SSSNBGV9 EUDAMED
0081008070SSSNGRWE EUDAMED
0810080701970-I2S-SSH8 EUDAMED
0810080701960-I2S-SSGH EUDAMED
00810080701499-DCOTV EUDAMED
00810080701907-SMO-SSS8 EUDAMED
Direct Marketing DI
00810080700383 EUDAMED
00810080701106 EUDAMED
00810080700918 EUDAMED
00810080701540 EUDAMED
00810080701007 EUDAMED
00810080701557 EUDAMED
00810080701496 EUDAMED
00810080700550 EUDAMED
00810080700604 EUDAMED
00810080701137 EUDAMED
00810080700505 EUDAMED
00810080701298 EUDAMED
00810080700741 EUDAMED
00810080700932 EUDAMED
00810080701250 EUDAMED
00810080701687 EUDAMED
00810080701120 EUDAMED
00810080701212 EUDAMED
00810080701724 EUDAMED
00810080701564 EUDAMED
00810080700758 EUDAMED
00810080700581 EUDAMED
00810080700437 EUDAMED
00810080700390 EUDAMED
00810080701809 EUDAMED
00810080700987 EUDAMED
00810080701861 EUDAMED
00810080700840 EUDAMED
00810080701502 EUDAMED
00810080700901 EUDAMED
00810080701359 EUDAMED
00810080700475 EUDAMED
00810080701465 EUDAMED
00810080701427 EUDAMED
00810080700925 EUDAMED
00810080700468 EUDAMED
00810080701816 EUDAMED
00810080701519 EUDAMED
00810080700673 EUDAMED
00810080701847 EUDAMED
00810080701311 EUDAMED
00810080701021 EUDAMED
00810080700789 EUDAMED
00810080701403 EUDAMED
00810080700574 EUDAMED
00810080701656 EUDAMED
00810080700444 EUDAMED
00810080701014 EUDAMED
00810080701533 EUDAMED
00810080701625 EUDAMED
00810080700406 EUDAMED
00810080700864 EUDAMED
00810080701090 EUDAMED
00810080701083 EUDAMED
00810080701335 EUDAMED
00810080701434 EUDAMED
00810080700833 EUDAMED
00810080701281 EUDAMED
00810080700697 EUDAMED
00810080701380 EUDAMED
00810080701526 EUDAMED
00810080700734 EUDAMED
00810080701342 EUDAMED
00810080700420 EUDAMED
00810080700567 EUDAMED
00810080700611 EUDAMED
00810080700376 EUDAMED
00810080701168 EUDAMED
00810080700666 EUDAMED
00810080700857 EUDAMED
00810080701038 EUDAMED
00810080700826 EUDAMED
00810080701595 EUDAMED
00810080701472 EUDAMED
00810080701267 EUDAMED
00810080700512 EUDAMED
00810080701700 EUDAMED
00810080701908 EUDAMED
00810080701236 EUDAMED
00810080701229 EUDAMED
00810080700642 EUDAMED
00810080701762 EUDAMED
00810080700659 EUDAMED
00810080700888 EUDAMED
00810080700482 EUDAMED
00810080701304 EUDAMED
00810080700413 EUDAMED
00810080701182 EUDAMED
00810080701052 EUDAMED
00810080701328 EUDAMED
00810080701694 EUDAMED
EMDN Code
Y063303,Y090342 EUDAMED
Y06120601 PASSIVE ANKLE-FOOT ORTHOSES EUDAMED
Y061209 KNEE ORTHOSES EUDAMED
Y061280 LOWER LIMB ORTHOSES - ACCESSORIES EUDAMED
Y060312 CERVICAL SPINE ORTHOSES 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

Surestep by Surestep, LLC — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS

Authorization Coverage (European Union — 27 member states)

Regulatory Authorizations

European Union Active

CE/MDR

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
Surestep, LLC
EUDAMED SRN
US-MF-000003047
Authorised Representative
Emergo Europe B.V. NL-AR-000000116

Sources (91)

  • EUDAMED cf9c3db8-e03b-4bfb-ad7b-3ffcd823761c 61 fields · synced Sep 18, 2026
  • EUDAMED e1e866e1-ffc2-4f9f-93e1-6bcd29cf046e 61 fields · synced May 11, 2026
  • EUDAMED feb0c19f-f6f6-4514-914c-ad664380ea15 61 fields · synced May 11, 2026
  • EUDAMED 160f2307-a3e6-475f-aa77-a29760c45f28 61 fields · synced May 11, 2026
  • EUDAMED ebaaa2ff-a362-45ca-8d58-8f9bacb49a4f 61 fields · synced May 16, 2026
  • EUDAMED eb3f77e2-69ad-44a0-b0bd-5145d0fabf54 61 fields · synced May 16, 2026
  • EUDAMED 5f4e65b7-3033-4202-be14-bcf1c81507ea 61 fields · synced May 16, 2026
  • EUDAMED 5d1e0d04-92bb-4691-a39c-3ce6e27532cc 61 fields · synced May 16, 2026
  • EUDAMED 4effb08f-1faa-4ee1-a428-9d9103283825 61 fields · synced May 16, 2026
  • EUDAMED 04fbde69-7794-4eb9-8ba4-52d72b431d28 61 fields · synced May 16, 2026
  • EUDAMED 3a894baa-8519-45c4-bef9-9a6a5535961d 61 fields · synced May 16, 2026
  • EUDAMED c8127faf-6bdd-41c4-92e8-d20026b6e90f 61 fields · synced May 16, 2026
  • EUDAMED 46464c3a-36e9-47e0-8d22-645dd6d848e5 61 fields · synced May 16, 2026
  • EUDAMED d283ca37-1a55-4566-825e-52ce91980922 61 fields · synced May 16, 2026
  • EUDAMED 7777c5a8-91d5-4f83-94bb-28e510a9be0a 61 fields · synced May 16, 2026
  • EUDAMED 9fd97a8e-d311-4e05-a4e2-c694fa9e1c42 61 fields · synced May 16, 2026
  • EUDAMED f37a94ca-1d3b-432e-9737-e40b55f45004 61 fields · synced May 16, 2026
  • EUDAMED 2cb6b3a3-0430-4489-b66c-193b904dd940 61 fields · synced May 17, 2026
  • EUDAMED 94a7123b-7aed-4882-9227-67fbd5d2d95a 61 fields · synced May 17, 2026
  • EUDAMED e6f64941-80f8-4b5f-add5-b4818fdf330e 61 fields · synced May 17, 2026
  • EUDAMED 31a1b709-bc47-4df6-b367-dba1bf123a13 61 fields · synced May 17, 2026
  • EUDAMED 63f70372-63ab-4377-9aea-74b8876d29a5 61 fields · synced May 17, 2026
  • EUDAMED c55a072b-3ce0-4037-91e0-bdbdb6747cff 61 fields · synced May 17, 2026
  • EUDAMED 9b27f9b7-feb4-4a8e-b8b4-c97868403832 61 fields · synced May 17, 2026
  • EUDAMED bcf6875a-7ed0-43c8-a6de-52051705cc4c 61 fields · synced May 17, 2026
  • EUDAMED c3209990-0968-4be4-9b88-1a4345a7c2d3 61 fields · synced May 17, 2026
  • EUDAMED 315ca54e-14ee-4b38-adaa-7d3548c40be1 61 fields · synced May 17, 2026
  • EUDAMED 79570047-8aee-4eaf-8f91-6442c250e14c 61 fields · synced May 17, 2026
  • EUDAMED 99ddcbef-5cb0-4380-b352-a80dd0a1548f 61 fields · synced May 17, 2026
  • EUDAMED 0e69e0d8-f5d7-4f7f-b68a-73450e96ad06 61 fields · synced May 17, 2026
  • EUDAMED aec91d4c-bfff-4378-8472-f8a7750acb35 61 fields · synced May 17, 2026
  • EUDAMED 7205e1fa-597f-4c31-83e6-a118a2f0ba64 61 fields · synced May 17, 2026
  • EUDAMED 059b7edf-5a8e-4784-99e7-c840961489c2 61 fields · synced May 17, 2026
  • EUDAMED e16203c4-6d4c-40a6-976a-281843457b8a 61 fields · synced May 17, 2026
  • EUDAMED 0c3febd0-387e-4cfe-8793-b1a3e4ab76d0 61 fields · synced May 17, 2026
  • EUDAMED 03d5eedb-c268-4dc8-ada8-f387fa75e049 61 fields · synced May 17, 2026
  • EUDAMED d2a4454e-c44d-43fa-906f-decb9ee4a5ec 61 fields · synced May 17, 2026
  • EUDAMED bf4a9fdc-57ab-44d9-aa7d-8184e6969c92 61 fields · synced May 17, 2026
  • EUDAMED 99525a34-721f-499d-906a-befe49f03db4 61 fields · synced May 17, 2026
  • EUDAMED 89c5cf1a-3faa-40da-8669-ffe938f57afb 61 fields · synced May 17, 2026
  • EUDAMED ab9d8cc8-3696-4695-a707-7c5b079d3c04 61 fields · synced May 17, 2026
  • EUDAMED 2abfc4ff-d0ec-446c-adba-fb99b2ef6060 61 fields · synced May 17, 2026
  • EUDAMED 140d242e-5355-49d7-9003-ca68ad396086 61 fields · synced May 17, 2026
  • EUDAMED c2473a8b-016b-4073-be9d-feeb8e15822a 61 fields · synced May 17, 2026
  • EUDAMED f4220dde-e343-4bb2-9e71-6695aa1c50ff 61 fields · synced May 17, 2026
  • EUDAMED deea2c81-e26f-4690-9ccc-aeefe71c9ec8 61 fields · synced May 17, 2026
  • EUDAMED 887496c7-87ca-461f-85d3-50b08b80fb33 61 fields · synced May 17, 2026
  • EUDAMED 81787126-57b8-46ad-ad0f-dd2332fe0341 61 fields · synced May 17, 2026
  • EUDAMED 6e3eff7c-90a4-4a54-a3f3-7360818a5ff8 61 fields · synced May 17, 2026
  • EUDAMED 46060530-a82d-436d-936a-62feec60e533 61 fields · synced May 17, 2026
  • EUDAMED 130ef678-8560-4229-b515-758dc3823719 61 fields · synced May 17, 2026
  • EUDAMED 6a2ee020-ba58-4f5a-abf5-9e04d77ba84d 61 fields · synced May 17, 2026
  • EUDAMED e4b3d790-1e9a-4dc6-9791-2139e1f4690a 61 fields · synced May 17, 2026
  • EUDAMED 77801d7f-bb0c-4367-bbbe-5fdc63758c2d 61 fields · synced May 18, 2026
  • EUDAMED 67913bd9-e2a9-408d-b260-994ba15f7899 61 fields · synced May 18, 2026
  • EUDAMED e126ab4b-c99c-4c97-bb0a-fa5267ea19cf 61 fields · synced May 18, 2026
  • EUDAMED 15732209-0533-4307-9ea7-6471480611b9 61 fields · synced May 18, 2026
  • EUDAMED 4651a611-6514-420d-b640-da1d88803327 61 fields · synced May 18, 2026
  • EUDAMED 7b4d99e6-5426-4883-a6b6-4500b2c40bfc 61 fields · synced May 18, 2026
  • EUDAMED f069ff61-7de8-483c-b00b-1d6c89b772ab 61 fields · synced May 18, 2026
  • EUDAMED 391763b4-cd05-40de-95bc-cb60d661456d 61 fields · synced May 18, 2026
  • EUDAMED 8ed6e30a-c97f-4192-85d0-eea157acd1de 61 fields · synced May 18, 2026
  • EUDAMED 31a7d23e-5817-4fc9-acc6-87f1f7afeaa4 61 fields · synced May 18, 2026
  • EUDAMED 994c4c94-8321-4db0-9780-7054e2235888 61 fields · synced May 18, 2026
  • EUDAMED 56e8b201-2b0e-4f9b-97c5-d3c2f313cd9f 61 fields · synced May 18, 2026
  • EUDAMED dca2dff9-08e7-4153-a892-3720c84cf6bb 61 fields · synced May 18, 2026
  • EUDAMED e3c2e789-2aaa-4efd-9744-770fb39b182d 61 fields · synced May 18, 2026
  • EUDAMED b897d974-3f1f-43c2-854e-8018a131489e 61 fields · synced May 18, 2026
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