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Electric Wheelchair

EUDAMEDFDA UDI

Class I (EU MDR)

Ref BC-EF1000Model BC-EA8000; BC-EA7001; BC-EA8001; BC-EA8002; BC-EA8003; BC-EA8004; BC-EA8005; BC-EA8006; BC-EA8007; BC-EA8008; BC-EA8009; BC-EA8010; BC-EA9000; BC-EA5521; BC-EC01;BC-EC02;BC-EA5515; BC-EA530; BC-EA5513; BC-EALD3; BC-ES6001; BC-ES6003,etcRef BC-EA8000FRef BC-EM806Ref BC-EW01Ref BC-EA8000MRRef BC-EALD4Ref BC-EA8000RRef BC-EM808Ref BC-ES6005Ref BC-EA8000FMRRef BC-EC8002-SRef BC-ES6001Ref BC-EM809Ref BC-EC8016Ref BC-EC8007Ref BC-EA8006Ref BC-EM800Ref BC-EA5517Ref BC-MS312Ref BC-MS310Ref BC-EM908Ref BC-EC8011Ref BC-EF1006Ref BC-EA5513Ref BC-MS305Ref BC-ES5516Ref BC-MS311Ref BC-EM600Ref BC-EM606Ref BC-ES8000Ref BC-EC8008Ref BC-EM609Ref BC-EA5519Ref BC-EM608Ref BC-EA8008Ref BC-EC8006

by Ningbo Baichen Medical Devices Co., Ltd.

Identity

Trade Name
Baichen FDA UDI
Generic Name
Electric-motor-driven wheelchair, occupant-controlled FDA UDI
Device Name
Electric Wheelchair EUDAMED
Model / Reference
BC-EA8000; BC-EA7001; BC-EA8001; BC-EA8002; BC-EA8003; BC-EA8004; BC-EA8005; BC-EA8006; BC-EA8007; BC-EA8008; BC-EA8009; BC-EA8010; BC-EA9000; BC-EA5521; BC-EC01;BC-EC02;BC-EA5515; BC-EA530; BC-EA5513; BC-EALD3; BC-ES6001; BC-ES6003,etc EUDAMED
BC-EF1000 EUDAMED
BC-EA8000F EUDAMED
BC-EM806 EUDAMED
BC-EW01 EUDAMED
BC-EA8000MR EUDAMED
BC-EALD4 EUDAMED
BC-EA8000R EUDAMED
BC-EM808 EUDAMED
BC-ES6005 EUDAMED
BC-EA8000FMR EUDAMED
BC-EC8002-S EUDAMED
BC-ES6001 EUDAMED
BC-EM809 EUDAMED
BC-EC8016 EUDAMED
BC-EC8007 EUDAMED
BC-EA8006 EUDAMED
BC-EM800 EUDAMED
BC-EA5517 EUDAMED
BC-MS312 EUDAMED
BC-MS310 EUDAMED
BC-EM908 EUDAMED
BC-EC8011 EUDAMED
BC-EF1006 EUDAMED
BC-EA5513 EUDAMED
BC-MS305 EUDAMED
BC-ES5516 EUDAMED
BC-MS311 EUDAMED
BC-EM600 EUDAMED
BC-EM606 EUDAMED
BC-ES8000 EUDAMED
BC-EC8008 EUDAMED
BC-EM609 EUDAMED
BC-EA5519 EUDAMED
BC-EM608 EUDAMED
BC-EA8008 EUDAMED
BC-EC8006 EUDAMED
Rubicon BC-EALD3 FDA UDI
Rubicon FDA UDI
Rubicon BC-EA5516 FDA UDI

Identifiers

Primary DI / UDI-DI
06975185621200 EUDAMED
06975185620388 EUDAMED
06975185621033 EUDAMED
06975185621231 EUDAMED
06975185620401 EUDAMED
06975185620296 EUDAMED
06975185620395 EUDAMED
06975185621040 EUDAMED
06975185620319 EUDAMED
06975185620418 EUDAMED
06975185621156 EUDAMED
06975185620159 EUDAMED
06975185621057 EUDAMED
06975185620098 EUDAMEDFDA UDI
06975185620135 EUDAMEDFDA UDI
06975185620074 EUDAMEDFDA UDI
06975185621194 EUDAMED
06975185621101 EUDAMED
06975185621026 EUDAMED
06975185620449 EUDAMED
06975185620241 EUDAMED
06975185620227 EUDAMED
06975185621088 EUDAMED
06975185621125 EUDAMED
06975185621217 EUDAMED
06975185620173 EUDAMED
06975185620371 EUDAMED
06975185620234 EUDAMED
06975185620470 EUDAMED
06975185620487 EUDAMED
06975185620364 EUDAMED
06975185621170 EUDAMED
06975185621019 EUDAMED
06975185620463 EUDAMED
06975185620494 EUDAMED
06975185621163 EUDAMED
Basic UDI-DI
697518562ewheelchair001YK EUDAMED
510(k) Number
K250475 FDA UDI
K232121 FDA UDI
FDA Product Code
ITI FDA UDI
EMDN Code
Y122127 ELECTRIC WHEELCHAIRS EUDAMED
GMDN Term
Electric-motor-driven wheelchair, occupant-controlled FDA UDI

Classification

Device Class
Class I EUDAMED
Class II FDA UDI
Regulation Number
890.3860 FDA UDI
Market of Registration
Austria EUDAMED
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

EUDAMEDFDA UDI

Single Use

No

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

No

EUDAMED

Incorporates Medicinal Product

No

EUDAMED

Prescription Use

No

FDA UDI

Over-the-Counter

Yes

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

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI

Electric Wheelchair by Ningbo Baichen Medical Devices Co., Ltd — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS

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
Ningbo Baichen Medical Devices Co., Ltd.
EUDAMED SRN
CN-MF-000021409
Authorised Representative
SUNGO Europe B.V. NL-AR-000000247

Sources (39)

  • EUDAMED fe80f97c-37a8-4883-9f70-d1934f177a66 61 fields · synced Sep 18, 2026
  • EUDAMED 414bb606-7544-434b-941a-7901f74d8ea6 61 fields · synced May 16, 2026
  • EUDAMED 562c3a33-c7fe-44a7-8d60-da2b8c7e9557 61 fields · synced May 16, 2026
  • EUDAMED 9517989d-a156-4b1d-bb87-f5601de8db43 61 fields · synced May 17, 2026
  • EUDAMED 47176b8a-bcc8-4f32-95ba-42b74ac6aed6 61 fields · synced May 17, 2026
  • EUDAMED 821a95e2-004f-42bb-b07a-bf65b26554f8 61 fields · synced May 18, 2026
  • EUDAMED 537d9120-2ac0-408e-ae1c-f5de47c92cb0 61 fields · synced May 18, 2026
  • EUDAMED 91d81b85-c40c-44d2-9f2f-74437f78512d 61 fields · synced May 18, 2026
  • EUDAMED 957947cf-116a-4666-add8-709a448f039f 61 fields · synced May 18, 2026
  • EUDAMED c86e373c-5003-4a74-b231-7d0e366f8a6d 61 fields · synced May 18, 2026
  • EUDAMED ff1d0831-6a60-4b4e-af83-62012e725987 61 fields · synced May 18, 2026
  • EUDAMED 05359352-a5f9-4809-88bf-f55516076b70 61 fields · synced May 18, 2026
  • EUDAMED 17b06c01-cead-4acf-b0c2-a31395438668 61 fields · synced May 18, 2026
  • FDA UDI 9169a0b6-c139-41f9-b819-ec10d6883e3e 33 fields · synced May 30, 2026
  • FDA UDI 282d53af-b4c0-499a-9d5b-80d932037c21 33 fields · synced May 30, 2026
  • FDA UDI 7f28f12e-6fca-4215-b50f-e5fb13e126d5 33 fields · synced May 30, 2026
  • EUDAMED ab2bb83c-af76-48f8-af65-ac10045e5083 61 fields · synced Jun 20, 2026
  • EUDAMED 29532bfb-6fcd-4f6b-81dc-84af5685e7b2 61 fields · synced Jul 9, 2026
  • EUDAMED 678e185d-6386-4ecb-b999-43ecca8ab642 61 fields · synced Jul 9, 2026
  • EUDAMED 98ce622b-e0f9-4fe6-afe3-e9ca7ca865cd 61 fields · synced Jul 10, 2026
  • EUDAMED bdca2732-faf1-4c4a-ad08-49e5cbe46b72 61 fields · synced Jul 11, 2026
  • EUDAMED 7c95df6d-2722-47f6-a880-c6eb151f15da 61 fields · synced Jul 12, 2026
  • EUDAMED 66bb4396-609d-4c81-b44c-b7db2dc8af67 61 fields · synced Jul 12, 2026
  • EUDAMED 71221ab1-8297-40e7-bf19-749908c574a8 61 fields · synced Jul 13, 2026
  • EUDAMED f35e7a1f-9ab5-482c-b814-53a881d88741 61 fields · synced Jul 15, 2026
  • EUDAMED 29625ee7-e1c7-4328-8c02-46a3e7e4b5fc 61 fields · synced Jul 17, 2026
  • EUDAMED f6a57f16-433c-4b16-91b4-e5a8ed50f66d 61 fields · synced Jul 17, 2026
  • EUDAMED 5806cb5c-bf1a-492c-93dd-6857913a2bb1 61 fields · synced Jul 20, 2026
  • EUDAMED fc6431b1-78eb-42cb-aa09-75295d5dc8b9 61 fields · synced Jul 21, 2026
  • EUDAMED 7ec748f9-11a6-41b0-9050-b1921b341a71 61 fields · synced Jul 21, 2026
  • EUDAMED 5e076655-69aa-41ba-b3f9-b2046c5aeb5a 61 fields · synced Jul 21, 2026
  • EUDAMED bc8666d9-cadd-46ec-97cc-0c26fd02ede0 61 fields · synced Jul 21, 2026
  • EUDAMED 7f987209-2491-4922-a8df-92829fc57309 61 fields · synced Jul 24, 2026
  • EUDAMED d17e3556-7a8c-4455-88a3-7702000f6a8b 61 fields · synced Jul 25, 2026
  • EUDAMED b336fc3e-f942-4a9e-b286-64a5dbbeaa16 61 fields · synced Jul 27, 2026
  • EUDAMED ba2eedb2-83d5-4504-842e-d942bbb7b2cd 61 fields · synced Aug 1, 2026
  • EUDAMED 7d85502d-46e7-4cfa-9e00-60cc856f6708 61 fields · synced Aug 1, 2026
  • EUDAMED 6d8dec80-d910-40ae-8996-6648a9c984cb 61 fields · synced Aug 2, 2026
  • EUDAMED ec7635f9-3e9f-4b2b-a6ca-66f950017568 61 fields · synced Sep 18, 2026