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Manual wheelchair

EUDAMED

Class I (EU MDR)

Ref 3001 46Model 3001, 3002, 218-23, 218-23 WHD, 118-23, 118-23 Plus, 218-24, 108-23, Primeo, Primeo Plus, 348-23, 318-23, Relax Comfort, 358-23, 228-24 J, 538-23, 538-23 Hemi, 538-23 ComfortRef J20-1801Ref Primeo Plus 39 Ref 358 - 23 40Ref 348 – 23 46 Ref 318 – 23 40 Ref 3001Ref 228 - 24 J 36Ref 218 – 24 43 Ref 118 - 23 48Ref 318 – 23 43Ref 218 – 24 40 Ref 218 – 23 WHD 60Ref 538 - 23 Hemi 46Ref Primeo Plus 45Ref 108 – 23 51 Ref 218 - 23 40Ref 538 - 23 46Ref 348 – 23 43Ref J70-1801Ref 538 - 23 48Ref 3001 56Ref 348 – 23 51 Ref 538 - 23 Hemi 40Ref 118 - 23 40Ref 3002 46Ref EB-FCTM18-BK-BKC-HBRef 538 - 23 Plus 46Ref 348 – 23 40Ref 538 - 23 Plus 48Ref Relax Comfort 39Ref 538 - 23 40Ref Relax Comfort 49Ref 3001 40Ref 538 - 23 Plus 40Ref 218 – 24 51 Ref 108 – 23 40 Ref Primeo 42Ref 348 – 23 48Ref 218 – 23 WHD 51Ref 108 – 23 46 Ref 3001 60Ref 118 - 23 Plus 46

by A & I Industries Ltd Shunde Foshan

Identity

Device Name
Manual wheelchair EUDAMED
Model / Reference
3001, 3002, 218-23, 218-23 WHD, 118-23, 118-23 Plus, 218-24, 108-23, Primeo, Primeo Plus, 348-23, 318-23, Relax Comfort, 358-23, 228-24 J, 538-23, 538-23 Hemi, 538-23 Comfort EUDAMED
3001 46 EUDAMED
J20-1801 EUDAMED
Primeo Plus 39 EUDAMED
358 - 23 40 EUDAMED
348 – 23 46 EUDAMED
318 – 23 40 EUDAMED
3001 EUDAMED
228 - 24 J 36 EUDAMED
218 – 24 43 EUDAMED
118 - 23 48 EUDAMED
318 – 23 43 EUDAMED
218 – 24 40 EUDAMED
218 – 23 WHD 60 EUDAMED
538 - 23 Hemi 46 EUDAMED
Primeo Plus 45 EUDAMED
108 – 23 51 EUDAMED
218 - 23 40 EUDAMED
538 - 23 46 EUDAMED
348 – 23 43 EUDAMED
J70-1801 EUDAMED
538 - 23 48 EUDAMED
3001 56 EUDAMED
348 – 23 51 EUDAMED
538 - 23 Hemi 40 EUDAMED
118 - 23 40 EUDAMED
3002 46 EUDAMED
EB-FCTM18-BK-BKC-HB EUDAMED
538 - 23 Plus 46 EUDAMED
348 – 23 40 EUDAMED
538 - 23 Plus 48 EUDAMED
Relax Comfort 39 EUDAMED
538 - 23 40 EUDAMED
Relax Comfort 49 EUDAMED
3001 40 EUDAMED
538 - 23 Plus 40 EUDAMED
218 – 24 51 EUDAMED
108 – 23 40 EUDAMED
Primeo 42 EUDAMED
348 – 23 48 EUDAMED
218 – 23 WHD 51 EUDAMED
108 – 23 46 EUDAMED
3001 60 EUDAMED
118 - 23 Plus 46 EUDAMED

Identifiers

Primary DI / UDI-DI
06977868800216 EUDAMED
06977868800957 EUDAMED
06977868800612 EUDAMED
06977868800551 EUDAMED
06977868800438 EUDAMED
06977868800469 EUDAMED
06977868800001 EUDAMED
06977868800513 EUDAMED
06977868800322 EUDAMED
06977868800681 EUDAMED
06977868800476 EUDAMED
06977868800315 EUDAMED
06977868800308 EUDAMED
06977868800827 EUDAMED
06977868800636 EUDAMED
06977868800407 EUDAMED
06977868800742 EUDAMED
06977868800773 EUDAMED
06977868800421 EUDAMED
06977868800995 EUDAMED
06977868800780 EUDAMED
06977868800247 EUDAMED
06977868800452 EUDAMED
06977868800803 EUDAMED
06977868800650 EUDAMED
06977868800278 EUDAMED
06977868801015 EUDAMED
06977868800872 EUDAMED
06977868800414 EUDAMED
06977868800889 EUDAMED
06977868800520 EUDAMED
06977868800759 EUDAMED
06977868800544 EUDAMED
06977868800209 EUDAMED
06977868800858 EUDAMED
06977868800353 EUDAMED
06977868800360 EUDAMED
06977868800582 EUDAMED
06977868800445 EUDAMED
06977868800285 EUDAMED
06977868800384 EUDAMED
06977868800254 EUDAMED
06977868800711 EUDAMED
Basic UDI-DI
697786880MwheelchairT8 EUDAMED
EMDN Code
Y122103 PUSH WHEELCHAIRS 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

Manual wheelchair by A & I Industries Ltd Shunde Foshan — 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
A & I Industries Ltd Shunde Foshan
EUDAMED SRN
CN-MF-000038647
Authorised Representative
SUNGO Europe B.V. NL-AR-000000247

Sources (43)

  • EUDAMED 3564a46b-efb0-47c6-90ea-9ce05ba49029 61 fields · synced Sep 18, 2026
  • EUDAMED 858b3bd9-1fe4-44ed-841c-906a93e7a882 61 fields · synced May 11, 2026
  • EUDAMED 85eb4775-46f6-4793-8e27-a938d6e209b0 61 fields · synced May 11, 2026
  • EUDAMED 9427e891-8ee4-4b08-8918-3496249aaf5b 61 fields · synced May 16, 2026
  • EUDAMED f3c8924d-13b9-49eb-a570-4e0dafd7d92b 61 fields · synced May 16, 2026
  • EUDAMED a53ea46e-d4a6-4f3f-8afb-b9749f93b041 61 fields · synced May 17, 2026
  • EUDAMED b2289581-ab93-4c27-8e25-e8253aead4ed 61 fields · synced May 17, 2026
  • EUDAMED df072fb9-c9af-47a9-80cd-7ab695398b8c 61 fields · synced May 17, 2026
  • EUDAMED cfa6c4d4-cdf4-4012-87ef-dad2f03d3e7c 61 fields · synced May 17, 2026
  • EUDAMED f742d51a-7280-4c24-928b-4d8b271baab0 61 fields · synced May 17, 2026
  • EUDAMED 7e44fd62-a8df-4156-b3e3-83b20c2856ce 61 fields · synced May 17, 2026
  • EUDAMED f3eb9046-7f99-4688-8edf-ab060ac74163 61 fields · synced May 17, 2026
  • EUDAMED 2a5dffe0-08cd-462b-a4d9-6170550e678f 61 fields · synced May 17, 2026
  • EUDAMED 28c0de01-5d21-4258-a9b3-fbe16ae64ef4 61 fields · synced May 17, 2026
  • EUDAMED e27b320e-5719-461a-8fa8-2743808f2573 61 fields · synced May 17, 2026
  • EUDAMED 0ca39475-e69b-464e-ba38-ae132e459961 61 fields · synced May 18, 2026
  • EUDAMED b8261ef5-8f2c-4a8d-80e5-1439c2547b16 61 fields · synced May 18, 2026
  • EUDAMED 65659191-2861-48d5-9a62-2e9295945a3a 61 fields · synced May 18, 2026
  • EUDAMED fd42be72-7ac4-40cf-99a0-32e882d7e993 61 fields · synced May 18, 2026
  • EUDAMED 748badb0-a6ce-4b48-b53e-e48751c6df66 61 fields · synced May 18, 2026
  • EUDAMED 1dd36175-5168-48a2-ba54-bafcdf552280 61 fields · synced May 18, 2026
  • EUDAMED 7f76b96f-74f2-4ddd-91a8-beb85f87cfac 61 fields · synced May 18, 2026
  • EUDAMED 2ed69862-18fb-48ad-8c9a-8e03b508917e 61 fields · synced May 18, 2026
  • EUDAMED 6e379686-6edb-4d28-97d8-810f03b17e5b 61 fields · synced May 18, 2026
  • EUDAMED 5a8b1e3c-17b7-4514-95be-049a1bb9c21b 61 fields · synced May 18, 2026
  • EUDAMED 5ae277d6-2192-4192-9f26-ca84773b2173 61 fields · synced May 18, 2026
  • EUDAMED 280ab2db-424f-4674-aef8-70cabe18d6b8 61 fields · synced May 18, 2026
  • EUDAMED 1a1ccfdf-d426-458e-9d39-50cfb94bf599 61 fields · synced May 18, 2026
  • EUDAMED be1a6383-71ea-41aa-a5af-d4dc7a64f92a 61 fields · synced May 18, 2026
  • EUDAMED 1d7a5a7f-64ee-4900-95ed-023ec966b1ff 61 fields · synced May 18, 2026
  • EUDAMED 586d0a02-fe43-4c11-9a8d-e872ba319912 61 fields · synced May 18, 2026
  • EUDAMED 9baa34b5-912c-45ca-b2e6-3c64db94f046 61 fields · synced May 18, 2026
  • EUDAMED 1add198a-5520-4f8b-8544-e751783733c3 61 fields · synced May 18, 2026
  • EUDAMED adef3b52-b732-479a-8618-7a588c5ae644 61 fields · synced May 18, 2026
  • EUDAMED 92c1dbab-c95c-4244-b381-8cd5ea1bf6bd 61 fields · synced May 18, 2026
  • EUDAMED 98e1cbb9-b5eb-4eb8-b2ad-e9e3a7134754 61 fields · synced May 18, 2026
  • EUDAMED c1dc5ed9-c031-407a-9575-9dfd4f6eddd5 61 fields · synced May 19, 2026
  • EUDAMED 0afb33d3-230e-4d2c-82de-de989fb71e4e 61 fields · synced May 19, 2026
  • EUDAMED 115784d6-8dce-469e-9ba8-aff1def5a942 61 fields · synced May 19, 2026
  • EUDAMED 1360e757-1815-4ec4-a40e-6a205b7930af 61 fields · synced May 19, 2026
  • EUDAMED f0a79a9a-3bf4-46ea-a5e4-9c7158d6437f 61 fields · synced May 19, 2026
  • EUDAMED 0eb88824-6de3-4201-bbcb-7558f72b7674 61 fields · synced May 19, 2026
  • EUDAMED 014d648d-ff93-4815-87f9-15ac2973a982 61 fields · synced May 19, 2026