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Wheelchair
EUDAMEDFDA 510(k)Class I (EU MDR)
Ref SKW9074Model SKW8001、SKW8001-12、SKW8002、SKW8002A、SKW8002B、SKW8002C、SKW8002D、SKW8003、SKW8004、SKW8005、SKW8006、SKW8008、SKW8009、SKW8010、SKW8012、SKW8020、etcRef SKW9013Ref SKW8073Ref SKW9037Ref SKW8065Ref SKW9020Ref SKW9064Ref SKW9045Ref SKW9030Ref SKW9059Ref SKW8077Ref SKW8050Ref SKW8008Ref SKW8071Ref SKW8076Ref SKW8063Ref SKW8052Ref SKW9065Ref SKW8036Ref SKW9053Ref SKW9075Ref SKW9022Ref SKW8002BRef SKW8042Ref SKW8048Ref SKW9077Ref SKW9054Ref SKW8049Ref SKW8047Ref SKW9062Ref SKW8062Ref SKW9039Ref SKW8003Ref SKW8040Ref SKW9034Ref SKW9076Ref SKW8035Ref SKW8012Ref SKW8029Ref SKW9036Ref SKW8044Ref SKW8002CRef SKW9044Ref SKW8028Ref SKW9005ARef SKW9040Ref SKW8033Ref SKW8021Ref SKW8039Ref SKW8054Ref SKW9038
Identity
- Device Name
- Wheelchair EUDAMED
- Model / Reference
- SKW8001、SKW8001-12、SKW8002、SKW8002A、SKW8002B、SKW8002C、SKW8002D、SKW8003、SKW8004、SKW8005、SKW8006、SKW8008、SKW8009、SKW8010、SKW8012、SKW8020、etc EUDAMEDSKW9074 EUDAMEDSKW9013 EUDAMEDSKW8073 EUDAMEDSKW9037 EUDAMEDSKW8065 EUDAMEDSKW9020 EUDAMEDSKW9064 EUDAMEDSKW9045 EUDAMEDSKW9030 EUDAMEDSKW9059 EUDAMEDSKW8077 EUDAMEDSKW8050 EUDAMEDSKW8008 EUDAMEDSKW8071 EUDAMEDSKW8076 EUDAMEDSKW8063 EUDAMEDSKW8052 EUDAMEDSKW9065 EUDAMEDSKW8036 EUDAMEDSKW9053 EUDAMEDSKW9075 EUDAMEDSKW9022 EUDAMEDSKW8002B EUDAMEDSKW8042 EUDAMEDSKW8048 EUDAMEDSKW9077 EUDAMEDSKW9054 EUDAMEDSKW8049 EUDAMEDSKW8047 EUDAMEDSKW9062 EUDAMEDSKW8062 EUDAMEDSKW9039 EUDAMEDSKW8003 EUDAMEDSKW8040 EUDAMEDSKW9034 EUDAMEDSKW9076 EUDAMEDSKW8035 EUDAMEDSKW8012 EUDAMEDSKW8029 EUDAMEDSKW9036 EUDAMEDSKW8044 EUDAMEDSKW8002C EUDAMEDSKW9044 EUDAMEDSKW8028 EUDAMEDSKW9005A EUDAMEDSKW9040 EUDAMEDSKW8033 EUDAMEDSKW8021 EUDAMEDSKW8039 EUDAMEDSKW8054 EUDAMEDSKW9038 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06979436861414 EUDAMED06979436860851 EUDAMED06979436860684 EUDAMED06979436861049 EUDAMED06979436860608 EUDAMED06979436860875 EUDAMED06979436861315 EUDAMED06979436861124 EUDAMED06979436860974 EUDAMED06979436861261 EUDAMED06979436860721 EUDAMED06979436860455 EUDAMED06979436860110 EUDAMED06979436860660 EUDAMED06979436860714 EUDAMED06979436860585 EUDAMED06979436860479 EUDAMED06979436861322 EUDAMED06979436860318 EUDAMED06979436861209 EUDAMED06979436861421 EUDAMED06979436860899 EUDAMED06979436860042 EUDAMED06979436860370 EUDAMED06979436860431 EUDAMED06979436861445 EUDAMED06979436861216 EUDAMED06979436860448 EUDAMED06979436860424 EUDAMED06979436861292 EUDAMED06979436860578 EUDAMED06979436861063 EUDAMED06979436860073 EUDAMED06979436860356 EUDAMED06979436861018 EUDAMED06979436861438 EUDAMED06979436860301 EUDAMED06979436860141 EUDAMED06979436860240 EUDAMED06979436861032 EUDAMED06979436860394 EUDAMED06979436860059 EUDAMED06979436861117 EUDAMED06979436860233 EUDAMED06979436860806 EUDAMED06979436861070 EUDAMED06979436860288 EUDAMED06979436860165 EUDAMED06979436860349 EUDAMED06979436860493 EUDAMED06979436861056 EUDAMED
- Basic UDI-DI
- 697943686WheelchairX8 EUDAMED
- EMDN Code
- Y122103 PUSH WHEELCHAIRS EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Germany 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
Wheelchair by Danyang Sunco Machinery Co.ltd — Class I — FDA_510K, MDR — listed in EUDAMED, FDA 510(k) — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
United States Active
FDA_510K
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K153328 | Class I | Active |
| EUDAMED | European Union | CE/MDR | 697943686WheelchairX8 | Class I | Active |
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Manufacturer
- Manufacturer
- Danyang Sunco Machinery Co.ltd
- EUDAMED SRN
- CN-MF-000051111
- Authorised Representative
- SUNGO Europe B.V. NL-AR-000000247
Sources (52)
- EUDAMED 3f199c96-47b0-406a-8c9a-613e4f2560a0 61 fields · synced Oct 6, 2026
- EUDAMED bc87afde-4583-4503-a968-22c1e1f0a18e 61 fields · synced May 11, 2026
- EUDAMED c956c0ea-4c99-4045-b82d-88633599dda3 61 fields · synced May 11, 2026
- EUDAMED e54424aa-ef9c-4890-8b27-0ff43b6a3e5f 61 fields · synced May 11, 2026
- EUDAMED 081ecadf-5dff-46f1-892c-910f47b13ad1 61 fields · synced May 11, 2026
- EUDAMED 19b0a2fe-bfda-4725-afa8-6fe096ca0e76 61 fields · synced May 11, 2026
- EUDAMED 180eb971-0234-48e4-83d4-48c766961933 61 fields · synced May 11, 2026
- EUDAMED 710f85a2-97c8-44bc-b611-a8a9b12c6716 61 fields · synced May 16, 2026
- EUDAMED 2ecfbac3-d5f8-4490-a6de-f49ef4b5be22 61 fields · synced May 16, 2026
- EUDAMED 1bf3aa93-9493-4c84-8afa-b1cc50a3c8d2 61 fields · synced May 16, 2026
- EUDAMED 478e1e54-9ec9-414c-a490-88e65f3923aa 61 fields · synced May 16, 2026
- EUDAMED bb938b81-7f54-474c-b7b7-57f00adf1c08 61 fields · synced May 16, 2026
- EUDAMED 6dbb2ca5-6497-4d39-bba9-1481e3494ae4 61 fields · synced May 16, 2026
- EUDAMED a4e9f406-3af4-4c1b-83f4-d53f93b8e9c2 61 fields · synced May 16, 2026
- EUDAMED 30ffaa08-2138-4235-ac67-6a7a0b4e3c42 61 fields · synced May 16, 2026
- EUDAMED 6c4ac28f-056d-4d26-8769-438d3952c82e 61 fields · synced May 16, 2026
- EUDAMED 1fc31204-3f39-4a49-bb0f-0f0f31ce4249 61 fields · synced May 16, 2026
- EUDAMED 82a86032-b593-4517-b617-34245ba28d65 61 fields · synced May 16, 2026
- EUDAMED 142121c5-5ae9-4621-99f3-e9d98a01764a 61 fields · synced May 16, 2026
- EUDAMED 899e3cd6-8f71-4b89-8a27-c475ff2e114e 61 fields · synced May 16, 2026
- EUDAMED 2f856adb-03e4-43f0-a832-a937ff0049b0 61 fields · synced May 17, 2026
- EUDAMED df048553-7864-4232-8bbe-6804365eadf5 61 fields · synced May 17, 2026
- EUDAMED ae2f5536-60ee-4b37-b4b3-b3d6cc8726ab 61 fields · synced May 17, 2026
- EUDAMED 0b934223-0cca-44f2-9e1b-0bf85ca664c3 61 fields · synced May 17, 2026
- EUDAMED ce6318fb-7b66-468e-99a4-948157607960 61 fields · synced May 17, 2026
- EUDAMED 23646258-5915-48e6-9cf8-1ac297165765 61 fields · synced May 17, 2026
- EUDAMED 080e803d-7076-4063-82ad-908a7cc4b738 61 fields · synced May 17, 2026
- EUDAMED 793289d0-7e68-40fa-8e40-d6e8ddd193bc 61 fields · synced May 17, 2026
- EUDAMED c26fcded-7c5d-4afb-a224-25a6ef87f712 61 fields · synced May 17, 2026
- EUDAMED 0601d953-2fb2-4275-9903-396b19461720 61 fields · synced May 17, 2026
- EUDAMED 96107b2d-5a64-4df5-9135-43eefcf72810 61 fields · synced May 17, 2026
- EUDAMED 3a42ea0e-cccb-490c-84c4-9a25cdd8ad34 61 fields · synced May 17, 2026
- EUDAMED 7a38f3c6-95ce-470c-98a5-6a479e6dcd8b 61 fields · synced May 17, 2026
- EUDAMED c755e784-6832-4b5b-91c8-1cf80a3f490a 61 fields · synced May 17, 2026
- EUDAMED 7e519b51-15a8-461a-89e2-9d7ffa09cbb8 61 fields · synced May 17, 2026
- EUDAMED 6006dc80-9b1a-485a-9b92-982c19c961a6 61 fields · synced May 17, 2026
- EUDAMED be16d4a0-c32c-4a12-9df6-853cfd2c0a83 61 fields · synced May 17, 2026
- EUDAMED 7b557691-b8a6-4dc9-97f5-e45d7ab6cd4f 61 fields · synced May 17, 2026
- EUDAMED a3b786da-0ae0-4207-8b7d-f13088b2903c 61 fields · synced May 17, 2026
- EUDAMED d506a795-0211-4ce0-a44b-1e6dde66c4a6 61 fields · synced May 17, 2026
- EUDAMED 40ed8156-5f56-48b6-9a90-d0d5ebb99a74 61 fields · synced May 17, 2026
- EUDAMED 68ccfa47-5394-434c-a11d-019220f6460c 61 fields · synced May 17, 2026
- EUDAMED c762933a-fe70-40ff-9b90-c1b38c9b5d5f 61 fields · synced May 17, 2026
- EUDAMED 868fe58d-8861-4bf8-9ec2-765717f0dde1 61 fields · synced May 18, 2026
- EUDAMED 44a37ed7-9e66-478e-af9b-142f89ac1d2e 61 fields · synced May 18, 2026
- EUDAMED 0ef85d56-f790-460d-a107-f8368856ffa0 61 fields · synced May 18, 2026
- EUDAMED ce265252-28f2-4957-bae0-82f58fd17f54 61 fields · synced May 18, 2026
- EUDAMED f109399f-a6bf-4828-a985-cf61cc922858 61 fields · synced May 18, 2026
- EUDAMED 1fec4e72-d114-474f-aad2-00fe7e319a27 61 fields · synced May 18, 2026
- EUDAMED df460631-62f1-42af-8d2e-97bc4d86a30e 61 fields · synced May 18, 2026
- EUDAMED 6714cbc0-568e-4c82-9da8-c7dbfcf2f431 61 fields · synced May 18, 2026
- FDA 510(k) K153328 1 fields · synced May 18, 2026