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Spasy
EUDAMEDClass IIa (EU MDR)
Ref SWM-4Ref SWMVPRef SWMPRef JMSWS20FRef CS6601-03Ref JMSWMPRef CS6601-06Ref SWVP-8BRef CS6601-04Ref SWS20Ref SWM-1Ref SWM10Ref SWM-4LRef SWVP-8TRef SWS15Ref SWDG-4ARef CS6601-05-10Ref CS6601-01Ref SWBS-9BRef JMSWM-3Ref JMSWM-4Ref JMSWM-1Ref JMSWSNTRef JMSWS10Ref SWM20Ref SWM-3Ref JMSWM-2T
Identity
- Trade Name
- SPASY EUDAMED
- Device Name
- SPASY EUDAMED
- Model / Reference
- SWM-4 EUDAMEDSWMVP EUDAMEDSWMP EUDAMEDJMSWS20F EUDAMEDCS6601-03 EUDAMEDJMSWMP EUDAMEDCS6601-06 EUDAMEDSWVP-8B EUDAMEDCS6601-04 EUDAMEDSWS20 EUDAMEDSWM-1 EUDAMEDSWM10 EUDAMEDSWM-4L EUDAMEDSWVP-8T EUDAMEDSWS15 EUDAMEDSWDG-4A EUDAMEDCS6601-05-10 EUDAMEDCS6601-01 EUDAMEDSWBS-9B EUDAMEDJMSWM-3 EUDAMEDJMSWM-4 EUDAMEDJMSWM-1 EUDAMEDJMSWSNT EUDAMEDJMSWS10 EUDAMEDSWM20 EUDAMEDSWM-3 EUDAMEDJMSWM-2T EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08809272562283 EUDAMED08809272562290 EUDAMED08809272562306 EUDAMED08809272561415 EUDAMED08809272564836 EUDAMED08809272561354 EUDAMED08809272564751 EUDAMED08809272564799 EUDAMED08809272564867 EUDAMED08809272562337 EUDAMED08809272562252 EUDAMED08809272564690 EUDAMED08809272565406 EUDAMED08809272562900 EUDAMED08809272562313 EUDAMED08809272562429 EUDAMED08809272564720 EUDAMED08809272564768 EUDAMED08809272562870 EUDAMED08809272561330 EUDAMED08809272561347 EUDAMED08809272561309 EUDAMED08809272561439 EUDAMED08809272561361 EUDAMED08809272564713 EUDAMED08809272562276 EUDAMED08809272561323 EUDAMED
- Basic UDI-DI
- B-08809272562283 EUDAMEDB-08809272562290 EUDAMEDB-08809272562306 EUDAMEDB-08809272561415 EUDAMEDB-08809272564836 EUDAMEDB-08809272561354 EUDAMEDB-08809272564751 EUDAMEDB-08809272564799 EUDAMEDB-08809272564867 EUDAMEDB-08809272562337 EUDAMEDB-08809272562252 EUDAMEDB-08809272564690 EUDAMEDB-08809272565406 EUDAMEDB-08809272562900 EUDAMEDB-08809272562313 EUDAMEDB-08809272562429 EUDAMEDB-08809272564720 EUDAMEDB-08809272564768 EUDAMEDB-08809272562870 EUDAMEDB-08809272561330 EUDAMEDB-08809272561347 EUDAMEDB-08809272561309 EUDAMEDB-08809272561439 EUDAMEDB-08809272561361 EUDAMEDB-08809272564713 EUDAMEDB-08809272562276 EUDAMEDB-08809272561323 EUDAMED
- EMDN Code
- A019011 INTRAOSSEOUS INFUSION AND VERTEBROPLASTY INFUSION NEEDLES AND KITS EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Category: Intraosseous infusion kit
Spasy by Seawon Meditech Co., Ltd. — Class IIa — MDD — listed in EUDAMED — regulatory data on deviCERTS
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Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-08809272562283 | Class IIa | Active |
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Manufacturer
- Manufacturer
- Seawon Meditech Co., Ltd.
- EUDAMED SRN
- KR-MF-000007442
- Authorised Representative
- Emergo Europe B.V. NL-AR-000000116
Sources (27)
- EUDAMED 4028e8e5-3a1c-4429-94b9-f1045d7afd01 61 fields · synced Aug 2, 2026
- EUDAMED 0fe02a5e-9121-4fab-834a-d4f21778954b 61 fields · synced May 11, 2026
- EUDAMED 6bb64852-791a-4f4c-a9aa-2721355db230 61 fields · synced May 16, 2026
- EUDAMED 24436d5a-4bb4-43a1-a9bc-c404e4eeca97 61 fields · synced May 17, 2026
- EUDAMED 5fb40beb-6043-4efb-9b32-f33b4fbba3eb 61 fields · synced May 17, 2026
- EUDAMED dc7acb42-6636-415d-ab01-1b712900f4db 61 fields · synced May 17, 2026
- EUDAMED 51e9a718-2de3-4284-bc53-991c756835f7 61 fields · synced May 17, 2026
- EUDAMED 0084346f-9266-4ce9-bd43-f21c5d0b22f8 61 fields · synced May 17, 2026
- EUDAMED 8668cdfb-c344-40c3-a8f1-824be70eb3d2 61 fields · synced May 17, 2026
- EUDAMED c7fa0887-09f1-417d-889a-b3980759617a 61 fields · synced May 17, 2026
- EUDAMED f4e526aa-7020-41fa-8b3a-b170e82afda0 61 fields · synced May 17, 2026
- EUDAMED c11da33c-223e-4ec0-a552-1ffc26dc45ef 61 fields · synced May 18, 2026
- EUDAMED 2395ea4b-656c-419c-b30a-4dbbeb295177 61 fields · synced May 18, 2026
- EUDAMED e6413e5a-bd0f-454a-a53a-aa1a7506d97e 61 fields · synced May 18, 2026
- EUDAMED e7cb6714-190d-4d5f-81d4-0ea8973fa32e 61 fields · synced May 18, 2026
- EUDAMED 1cd689be-b1e5-4c67-8193-b35b02475356 61 fields · synced May 18, 2026
- EUDAMED 68719e3d-5be7-41f1-975f-e3801cfbb5a6 61 fields · synced May 18, 2026
- EUDAMED a8245786-5a73-413c-8df8-259cec684406 61 fields · synced May 18, 2026
- EUDAMED 3865683e-fe43-4f32-bf60-6107ff3d16ac 61 fields · synced May 18, 2026
- EUDAMED 26dceb4e-7016-45dc-ad90-568b1f8b5645 61 fields · synced May 18, 2026
- EUDAMED b4fb3e80-f88e-46b9-8ec2-ff4d105fe763 61 fields · synced May 18, 2026
- EUDAMED 944826b0-4c7f-4637-af64-225ca39ce8d9 61 fields · synced May 18, 2026
- EUDAMED 6ba16780-5f33-4c9a-ad02-4ab236532525 61 fields · synced May 18, 2026
- EUDAMED 4b5c0b01-4b01-40ca-8471-db6ed26e5c86 61 fields · synced May 18, 2026
- EUDAMED 8b9938f6-0e76-4f18-ae35-55718419be21 61 fields · synced May 18, 2026
- EUDAMED b5831ecc-2302-4f0a-9bde-aedb5db03b92 61 fields · synced May 19, 2026
- EUDAMED bbaeaa67-dd29-4d2b-bda5-a889fca3f4cc 61 fields · synced May 19, 2026