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Saebo

EUDAMED

Class I (EU MDR)

Ref G1-GL-LG-XL-R-1Model SaeboGloveRef G1-GL-SM-XS-R-1Ref G1-GL-MD-MD-L-1Ref G1-GL-MD-XS-L-1Ref S1-SS-10-SM-L-1Model Saebo StretchRef S1-SS-10-SM-R-1Ref G1-GL-MD-LG-R-1Ref K7-SG-10-SD-N-1Ref S1-SS-10-MD-L-1Ref S1-SS-10-LG-R-1Ref K1-MM-200-SD-N-1Model SaeboMASminiRef G1-GL-LG-LG-L-1Ref G1-GL-MD-SM-R-1Ref G1-GL-MD-SM-L-1Ref S3-KT-14-SD-N-1Model SaeboStepRef G1-GL-MD-LG-L-1Ref G1-GL-SM-XS-L-1Ref S1-SS-10-LG-L-1Ref G1-GL-LG-LG-R-1

by Saebo Inc.

Identity

Trade Name
Saebo EUDAMED
Device Name
SaeboGlove, Complete Kit, Shell EUDAMED
SaeboStretch, Left small EUDAMED
SaeboMASmini EUDAMED
SaeboStep , complete kit EUDAMED
Model / Reference
SaeboGlove EUDAMED
G1-GL-LG-XL-R-1 EUDAMED
G1-GL-SM-XS-R-1 EUDAMED
G1-GL-MD-MD-L-1 EUDAMED
G1-GL-MD-XS-L-1 EUDAMED
Saebo Stretch EUDAMED
S1-SS-10-SM-L-1 EUDAMED
S1-SS-10-SM-R-1 EUDAMED
G1-GL-MD-LG-R-1 EUDAMED
K7-SG-10-SD-N-1 EUDAMED
S1-SS-10-MD-L-1 EUDAMED
S1-SS-10-LG-R-1 EUDAMED
SaeboMASmini EUDAMED
K1-MM-200-SD-N-1 EUDAMED
G1-GL-LG-LG-L-1 EUDAMED
G1-GL-MD-SM-R-1 EUDAMED
G1-GL-MD-SM-L-1 EUDAMED
SaeboStep EUDAMED
S3-KT-14-SD-N-1 EUDAMED
G1-GL-MD-LG-L-1 EUDAMED
G1-GL-SM-XS-L-1 EUDAMED
S1-SS-10-LG-L-1 EUDAMED
G1-GL-LG-LG-R-1 EUDAMED

Identifiers

Primary DI / UDI-DI
00850331006376 EUDAMED
00850331006307 EUDAMED
00850331006260 EUDAMED
00850331006246 EUDAMED
00850331006000 EUDAMED
00850331006031 EUDAMED
00850331006352 EUDAMED
00850331006512 EUDAMED
00850331006017 EUDAMED
00850331006055 EUDAMED
00810018350918 EUDAMED
00850331006284 EUDAMED
00850331006338 EUDAMED
00850331006253 EUDAMED
00810018351526 EUDAMED
00850331006277 EUDAMED
00850331006222 EUDAMED
00850331006024 EUDAMED
00850331006369 EUDAMED
Basic UDI-DI
0850331006SaeboGloveX5 EUDAMED
0850331006SaeboStretchFE EUDAMED
081001835SaeboMASminiB7 EUDAMED
0850331006SaeboStepT4 EUDAMED
EMDN Code
Y060613 WRIST-HAND-FINGERS ORTHOSES EUDAMED
Y060612 WRIST-HAND ORTHOSES EUDAMED
Y241899 ARM, HAND, FINGER FUNCTION AID AND/OR SUBSTITUTION DEVICES - OTHER EUDAMED
Y06120601 PASSIVE ANKLE-FOOT ORTHOSES EUDAMED

Classification

Device Class
Class I EUDAMED
Market of Registration
Austria 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

Saebo by Saebo Inc. — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS

Authorization Coverage (European Union — 27 member states)

Regulatory Authorizations

European Union Active

CE/MDR

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Manufacturer

Manufacturer
Saebo Inc.
EUDAMED SRN
US-MF-000052039
Authorised Representative
European Healthcare & Device Solutions Ltd. IE-AR-000003999

Sources (19)

  • EUDAMED d2d113dc-053d-4a55-bde3-6487846367f1 61 fields · synced Aug 4, 2026
  • EUDAMED 4599e0c8-6e92-482f-b749-504c717c2ac1 61 fields · synced May 16, 2026
  • EUDAMED eb2ed781-2f37-4698-bdac-94b98c1e29bf 61 fields · synced May 16, 2026
  • EUDAMED 34a44521-6f8a-4cee-86ba-84c0b1d3db3c 61 fields · synced May 16, 2026
  • EUDAMED c8a5c66a-d972-434a-bcdd-1bc18233e104 61 fields · synced May 16, 2026
  • EUDAMED d10d4196-6a77-4201-818b-dd8a8c9ab002 61 fields · synced May 16, 2026
  • EUDAMED 487ba864-3431-4f18-80fa-184808d892d4 61 fields · synced May 17, 2026
  • EUDAMED 4c3de368-a261-47b3-bbf7-6c0b6c3ac8f2 61 fields · synced May 17, 2026
  • EUDAMED 08c70164-9265-40d6-b6db-fd5400784945 61 fields · synced May 17, 2026
  • EUDAMED eed49018-cba4-472a-854d-599b7d05f906 61 fields · synced May 17, 2026
  • EUDAMED 7a4b2fd7-6d08-44fb-aaf3-d010f1877ea7 61 fields · synced May 17, 2026
  • EUDAMED 8d46db9c-7790-483a-b189-85e0ccb288c2 61 fields · synced May 17, 2026
  • EUDAMED df91fdea-8f01-494e-81d3-0cfb47bbb5d0 61 fields · synced May 17, 2026
  • EUDAMED 08a2dade-8cbb-4a14-a0d8-3f1c06a99ee0 61 fields · synced May 18, 2026
  • EUDAMED 7fa5f419-f3e9-481a-9fad-42206ad75339 61 fields · synced May 18, 2026
  • EUDAMED 3b774d7a-1f3b-48c9-b370-94c941297fcc 61 fields · synced May 18, 2026
  • EUDAMED 2ac13726-b484-4fa9-a7c4-0d7fde3a1516 61 fields · synced May 18, 2026
  • EUDAMED 7c8affad-05ee-41af-93db-63f752caf506 61 fields · synced May 19, 2026
  • EUDAMED 3d054ebd-618b-4603-9f97-9cc3e2ced881 61 fields · synced May 19, 2026