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Reusable Pulse Oximeter Probe

EUDAMEDFDA UDI

Class IIb (EU MDR)

Ref ODM-S0040B-LRef S0010G-SRef S0026B-SRef S0010D-SRef S0010F-SRef S0010E-SRef S0010B-SRef S0026F-SRef S0010C-SRef S0010P-SRef 635144164Ref S0125G-LRef 635221652Ref S0442E-LRef 635190734Ref S0190D-LRef S0190I-LRef S0190E-LRef 635124164Ref 635324502Ref 635194506Ref 635210734Ref 635430734Ref S0026E-SRef S0026C-LRef 635194164Model S0010I-SRef S0190C-L

by Shenzhen Med-link Electronics Tech Co., Ltd.

Identity

Trade Name
Reusable Pulse Oximeter Probe EUDAMED
Med-link FDA UDI
Generic Name
Pulse oximeter probe, reusable FDA UDI
Device Name
Reusable Pulse Oximeter Probe EUDAMED
Model / Reference
ODM-S0040B-L EUDAMED
S0010G-S EUDAMED
S0026B-S EUDAMED
S0010D-S EUDAMED
S0010F-S EUDAMED
S0010E-S EUDAMED
S0010B-S EUDAMED
S0026F-S EUDAMED
S0010C-S EUDAMED
S0010P-S EUDAMED
635144164 EUDAMED
S0125G-L EUDAMED
635221652 EUDAMED
S0442E-L EUDAMED
635190734 EUDAMED
S0190D-L EUDAMED
S0190I-L EUDAMED
S0190E-L EUDAMED
635124164 EUDAMED
635324502 EUDAMED
635194506 EUDAMED
635210734 EUDAMED
635430734 EUDAMED
S0026E-S EUDAMED
S0026C-L EUDAMED
635194164 EUDAMED
S0010I-S EUDAMED
S0190C-L EUDAMED
S0044D-S FDA UDI

Identifiers

Primary DI / UDI-DI
06944414052719 EUDAMED
06944414007559 EUDAMEDFDA UDI
06944414012744 EUDAMEDFDA UDI
06944414013345 EUDAMED
06944414054492 EUDAMED
06944414054683 EUDAMED
06944414009508 EUDAMED
06944414010481 EUDAMED
06944414034784 EUDAMED
06944414010634 EUDAMED
06944414007566 EUDAMED
06944414024372 EUDAMED
06944414041003 EUDAMED
06944414027199 EUDAMED
06944414036597 EUDAMED
06944414010580 EUDAMED
06944414035323 EUDAMED
06944414058551 EUDAMED
06944414087681 EUDAMED
06944414013710 EUDAMED
06944414090896 EUDAMED
06944414093620 EUDAMED
06944414013659 EUDAMED
06944414086400 EUDAMED
06944414092494 EUDAMED
06944414078429 EUDAMED
06944414090810 EUDAMED
06944414093842 EUDAMED
06944414093903 EUDAMED
06944414093880 EUDAMED
06944414093354 EUDAMED
06944414013734 EUDAMED
06944414081924 EUDAMED
06944414096799 EUDAMED
06944414013666 EUDAMED
06944414090865 EUDAMED
06944414090940 EUDAMED
06944414013635 EUDAMED
06944414090957 EUDAMED
06944414082556 EUDAMED
06944414080354 EUDAMED
06944414090797 EUDAMED
06944414090803 EUDAMED
06944414021302 EUDAMED
06944414033053 EUDAMED
06944414087667 EUDAMED
06944414090889 EUDAMED
06944414099622 EUDAMED
06944414080538 EUDAMED
06944414096782 EUDAMED
06944414053501 EUDAMED
06944414093859 EUDAMED
Basic UDI-DI
69444140104SR EUDAMED
510(k) Number
K083010 FDA UDI
FDA Product Code
DQA FDA UDI
EMDN Code
C900301 PULSE OXIMETER SENSORS EUDAMED
GMDN Term
Pulse oximeter probe, reusable FDA UDI

Classification

Device Class
Class IIb EUDAMED
Class II FDA UDI
Regulation Number
870.2700 FDA UDI
Market of Registration
Italy EUDAMED
Germany EUDAMED
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

EUDAMEDFDA UDI

Single Use

Yes

FDA UDI

Implantable

No

EUDAMEDFDA UDI

Reusable

No

EUDAMED

Contains Latex

No

EUDAMEDFDA UDI

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

Yes

EUDAMED

Incorporates Medicinal Product

No

EUDAMED

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

No

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI

Reusable Pulse Oximeter Probe by Shenzhen Med-link Electronics Tech Co., Ltd. — Class IIb — MDR, FDA UDI — listed in EUDAMED, FDA GUDID

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Active

CE/MDR

United States Pending data

FDA UDI

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

Manufacturer

Manufacturer
Shenzhen Med-link Electronics Tech Co., Ltd.
EUDAMED SRN
CN-MF-000011145
Authorised Representative
Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001

Sources (54)

  • EUDAMED 6d03a9ba-6cb4-48c8-a4c8-2ae826513bef 61 fields · synced Sep 18, 2026
  • FDA UDI f8a5de44-826b-4b29-a17a-b04ad13930fe 33 fields · synced May 29, 2026
  • FDA UDI d918e795-af48-4f49-a6f5-d0128f4521a6 33 fields · synced May 30, 2026
  • EUDAMED 93ccf41f-e05b-4462-a22a-b5faf4e323d3 61 fields · synced Jul 8, 2026
  • EUDAMED 8c535616-7607-42f5-9c48-7753ca5533d3 61 fields · synced Jul 8, 2026
  • EUDAMED 4052c0ed-ae2f-48cb-af05-414678df232d 61 fields · synced Jul 8, 2026
  • EUDAMED 9589c6d8-9219-40c0-97e4-503ef8a19b6d 61 fields · synced Jul 8, 2026
  • EUDAMED 8884a724-40cc-4486-a0a0-75e8202baec6 61 fields · synced Jul 8, 2026
  • EUDAMED b16f66e2-f970-4bba-b12e-4ceba1bf06f2 61 fields · synced Jul 8, 2026
  • EUDAMED 4502ea6d-eaf7-4319-8d8b-5daf58f9fe48 61 fields · synced Jul 8, 2026
  • EUDAMED 083c63e6-6eae-4f93-9615-3c5d521c8dea 61 fields · synced Jul 8, 2026
  • EUDAMED fa62c9dd-d9ee-4ffd-8551-bdf772e1dcc9 61 fields · synced Jul 8, 2026
  • EUDAMED e5def40b-8dc1-4c64-b0e8-63bbc2bfb5f7 61 fields · synced Jul 8, 2026
  • EUDAMED c0889c7f-a3af-4cbc-8bf5-4abdb9d80566 61 fields · synced Jul 8, 2026
  • EUDAMED 33788de2-a335-4aa6-bf21-5a8e45cfa009 61 fields · synced Jul 8, 2026
  • EUDAMED 5aebf56b-2c1d-4433-90e2-b1ccad364093 61 fields · synced Jul 8, 2026
  • EUDAMED 2f333795-2ed5-4790-973d-949a0f9a9b0a 61 fields · synced Jul 8, 2026
  • EUDAMED 7f163187-0920-49b4-bdff-ce540e701679 61 fields · synced Jul 8, 2026
  • EUDAMED f5a4c1c9-8aab-43df-b977-0c62a6af5870 61 fields · synced Jul 8, 2026
  • EUDAMED e0ed2883-60db-4109-b540-f71320774bc2 61 fields · synced Jul 8, 2026
  • EUDAMED be5a43a0-3482-4c7d-aab1-5900553a96e3 61 fields · synced Jul 9, 2026
  • EUDAMED 207b4db9-a830-4fb8-b9e9-737b76c15a1a 61 fields · synced Jul 9, 2026
  • EUDAMED f928e8ef-0964-45c5-a776-09aa595261b9 61 fields · synced Jul 9, 2026
  • EUDAMED 02b247c4-289b-4bd8-b8eb-d23b5341bdd4 61 fields · synced Jul 9, 2026
  • EUDAMED 92a5f32f-ed16-4cb1-9b86-01366f98570e 61 fields · synced Jul 10, 2026
  • EUDAMED 361b470a-d249-4c63-af5c-312fd592bcc4 61 fields · synced Jul 10, 2026
  • EUDAMED 6c34cbce-f021-48d9-971d-eff8a06d29f0 61 fields · synced Jul 10, 2026
  • EUDAMED 8fcb73da-6e3b-47d8-9e8f-e880f52fd1cd 61 fields · synced Jul 11, 2026
  • EUDAMED 4719bdd4-951b-4525-8ccb-100348083372 61 fields · synced Jul 11, 2026
  • EUDAMED 7c511bec-8541-4c24-98a9-94ff9211cd81 61 fields · synced Jul 13, 2026
  • EUDAMED 9bf813f3-4338-46b4-9d3a-a273b33f4ad3 61 fields · synced Jul 13, 2026
  • EUDAMED b9539791-02f5-4bde-a94d-740beb5f2754 61 fields · synced Jul 15, 2026
  • EUDAMED c349b6af-2349-4648-9d2f-b90d0a083e47 61 fields · synced Jul 15, 2026
  • EUDAMED 2c43078e-b6dd-49ca-b666-e20152ab137a 61 fields · synced Jul 17, 2026
  • EUDAMED e6f55bfe-dba2-4650-bfa2-934257c1eca7 61 fields · synced Jul 18, 2026
  • EUDAMED dd5d5537-c084-46b2-8805-7ef898d05689 61 fields · synced Jul 18, 2026
  • EUDAMED 0c567883-dbc0-4054-a56f-b33cf4506f68 61 fields · synced Jul 18, 2026
  • EUDAMED 4a4ec451-6bbf-42be-9994-45b98dabe5b6 61 fields · synced Jul 18, 2026
  • EUDAMED a60128a7-3405-45d6-87f6-e91bced3b253 61 fields · synced Jul 19, 2026
  • EUDAMED 54d859c0-89aa-4305-9cc4-f34a4b161f29 61 fields · synced Jul 20, 2026
  • EUDAMED ed389e73-2ec9-41a9-a0c1-c314579b90d2 61 fields · synced Jul 22, 2026
  • EUDAMED 715c481d-8bc5-44e1-9d93-4b7e8d9fd7c4 61 fields · synced Jul 24, 2026
  • EUDAMED f700d4a6-1a06-40a5-b736-c2dcbae545c8 61 fields · synced Jul 26, 2026
  • EUDAMED d2cc13b4-2c57-437c-8040-879baa4aac94 61 fields · synced Jul 29, 2026
  • EUDAMED 1c74a470-0241-4d87-880e-d990d776ccc9 61 fields · synced Aug 1, 2026
  • EUDAMED 4e4ae70d-b49c-4eed-a6a2-5a76fdaa2296 61 fields · synced Aug 1, 2026
  • EUDAMED 8ece3a5a-1a3b-49e0-a3a2-8507f7cb33df 61 fields · synced Aug 1, 2026
  • EUDAMED 4ea4a0cb-3d9d-4081-b22a-dcac4c22e3b8 61 fields · synced Aug 1, 2026
  • EUDAMED b1614b9f-aea4-4672-8342-530e5279c024 61 fields · synced Aug 2, 2026
  • EUDAMED 3dee81d1-bd63-4207-a1db-4d55f1c1f2c1 61 fields · synced Aug 3, 2026
  • EUDAMED 52449754-b83e-48c5-815a-1c1e860d039f 61 fields · synced Aug 4, 2026
  • EUDAMED c9470be6-e480-4a5b-af7b-a70087e87d17 61 fields · synced Aug 4, 2026
  • EUDAMED 44b19ae4-bd5a-44f4-a791-f04cdad0d204 61 fields · synced Sep 17, 2026
  • EUDAMED 33d7391a-93ac-4b4e-b269-89227f3e04f9 61 fields · synced Sep 18, 2026