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Splint
EUDAMEDClass I (EU MDR)
Ref DW-VS4Ref DW-FS02Ref DW-VS5Ref DW-FS02-L-83Ref DW-FS02-A-61Ref DW-FS03-A-25Ref DW-FA012-45Ref DW-FT11Ref DW-FS03-L-32Ref DW-FT07Ref DW-FT06Ref DW-FS01-A-58Ref DW-FT03Ref DW-FS01Ref DW-FS02-A-69Ref DW-FS03-E-15Ref DW-FA012-100Ref DW-FS04-A-40Ref DW-FS02-F-33Ref DW-FA005CRef DW-FA012-61Ref DW-FT02Ref DW-VS2Ref DW-FT04Ref DW-FS03-L-25Ref DW-SP03Ref DW-FT10Ref DW-FS01-L-66Ref DW-FS03-A-32Ref DW-FA012-91Ref DW-FA005ARef DW-VS7Ref DW-VS1
Identity
- Trade Name
- Splint EUDAMED
- Device Name
- Splint EUDAMED
- Model / Reference
- DW-VS4 EUDAMEDDW-FS02 EUDAMEDDW-VS5 EUDAMEDDW-FS02-L-83 EUDAMEDDW-FS02-A-61 EUDAMEDDW-FS03-A-25 EUDAMEDDW-FA012-45 EUDAMEDDW-FT11 EUDAMEDDW-FS03-L-32 EUDAMEDDW-FT07 EUDAMEDDW-FT06 EUDAMEDDW-FS01-A-58 EUDAMEDDW-FT03 EUDAMEDDW-FS01 EUDAMEDDW-FS02-A-69 EUDAMEDDW-FS03-E-15 EUDAMEDDW-FA012-100 EUDAMEDDW-FS04-A-40 EUDAMEDDW-FS02-F-33 EUDAMEDDW-FA005C EUDAMEDDW-FA012-61 EUDAMEDDW-FT02 EUDAMEDDW-VS2 EUDAMEDDW-FT04 EUDAMEDDW-FS03-L-25 EUDAMEDDW-SP03 EUDAMEDDW-FT10 EUDAMEDDW-FS01-L-66 EUDAMEDDW-FS03-A-32 EUDAMEDDW-FA012-91 EUDAMEDDW-FA005A EUDAMEDDW-VS7 EUDAMEDDW-VS1 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06977728545257 EUDAMED06977728545356 EUDAMED06977728545264 EUDAMED06977728545417 EUDAMED06977728545370 EUDAMED06977728545479 EUDAMED06977728545547 EUDAMED06977728545691 EUDAMED06977728545431 EUDAMED06977728545653 EUDAMED06977728545646 EUDAMED06977728545325 EUDAMED06977728545615 EUDAMED06977728545301 EUDAMED06977728545387 EUDAMED06977728545455 EUDAMED06977728545578 EUDAMED06977728545523 EUDAMED06977728545363 EUDAMED06977728545219 EUDAMED06977728545554 EUDAMED06977728545608 EUDAMED06977728545233 EUDAMED06977728545622 EUDAMED06977728545448 EUDAMED06977728545196 EUDAMED06977728545684 EUDAMED06977728545349 EUDAMED06977728545462 EUDAMED06977728545561 EUDAMED06977728545202 EUDAMED06977728545288 EUDAMED06977728545226 EUDAMED
- Basic UDI-DI
- 697772854DWSPXE EUDAMED
- Direct Marketing DI
- 06977728545257 EUDAMED06977728545356 EUDAMED06977728545264 EUDAMED06977728545417 EUDAMED06977728545370 EUDAMED06977728545479 EUDAMED06977728545547 EUDAMED06977728545691 EUDAMED06977728545431 EUDAMED06977728545653 EUDAMED06977728545646 EUDAMED06977728545325 EUDAMED06977728545615 EUDAMED06977728545301 EUDAMED06977728545387 EUDAMED06977728545455 EUDAMED06977728545578 EUDAMED06977728545523 EUDAMED06977728545363 EUDAMED06977728545219 EUDAMED06977728545554 EUDAMED06977728545608 EUDAMED06977728545233 EUDAMED06977728545622 EUDAMED06977728545448 EUDAMED06977728545196 EUDAMED06977728545684 EUDAMED06977728545349 EUDAMED06977728545462 EUDAMED06977728545561 EUDAMED06977728545202 EUDAMED06977728545288 EUDAMED06977728545226 EUDAMED
- EMDN Code
- M03050299 BANDAGES AND SPLINTS - OTHER 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
Category: Hand/finger splint, reusable
Splint by Suzhou Ireland Medical Equipment Co., Ltd. — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
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Also classified as Hand/finger splint, reusable.
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- Plastalume — BROWNMED, INC. · Class I
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 697772854DWSPXE | Class I | Active |
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Manufacturer
- Manufacturer
- Suzhou Ireland Medical Equipment Co., Ltd.
- EUDAMED SRN
- CN-MF-000043757
- Authorised Representative
- MedPath GmbH DE-AR-000000087
Sources (33)
- EUDAMED cc244eae-3f7e-44b5-90ba-2a1ffd594e1a 61 fields · synced Sep 17, 2026
- EUDAMED 2e79d3c9-ae0f-47e8-82df-44b356a421dc 61 fields · synced May 17, 2026
- EUDAMED fa090b0f-ede4-4f53-a28b-13a5c1ec45ca 61 fields · synced May 17, 2026
- EUDAMED cc5ab794-95df-437c-bef0-12a768101d26 61 fields · synced May 17, 2026
- EUDAMED 67e1e680-0426-4100-a09f-64050bba8a2a 61 fields · synced May 17, 2026
- EUDAMED 98c72906-3cda-4cd9-846d-d697620bd875 61 fields · synced May 17, 2026
- EUDAMED 08756394-2291-4c93-b498-b816700ef56f 61 fields · synced May 17, 2026
- EUDAMED 63a45f0e-b7d6-497e-851c-a8493ced5d8e 61 fields · synced May 17, 2026
- EUDAMED a83ce626-e316-467c-a725-0c6ea8cc8756 61 fields · synced May 17, 2026
- EUDAMED dce35a71-4967-425b-8d08-bf0eab319f86 61 fields · synced May 17, 2026
- EUDAMED 973ef47f-3b4c-40e0-ba91-acaf9c598d11 61 fields · synced May 17, 2026
- EUDAMED 95b40623-eed6-488c-8da6-cba246c2172e 61 fields · synced May 17, 2026
- EUDAMED 9c8a2496-aa28-4eea-9486-241711a202f1 61 fields · synced May 18, 2026
- EUDAMED 70acc07b-7e3f-4a5d-a95a-8e9c1313e2f2 61 fields · synced May 18, 2026
- EUDAMED 362a7467-bec9-4c74-9b44-742b5a1354aa 61 fields · synced May 18, 2026
- EUDAMED 3159847c-5bc8-4729-9cde-e6cfc14f6e73 61 fields · synced May 18, 2026
- EUDAMED 392a1a6d-0f06-4f29-b91f-519d9b359fc8 61 fields · synced May 18, 2026
- EUDAMED ca8bc309-683d-41f0-8c48-74dcfaba336e 61 fields · synced May 18, 2026
- EUDAMED f798a0ae-a550-4182-a653-9e252e4fff8f 61 fields · synced May 18, 2026
- EUDAMED 58009f78-1e36-4d34-8cd3-ccfa7cd4b756 61 fields · synced May 18, 2026
- EUDAMED fc5b3a5b-34c1-405a-b387-d1e8dd60b61e 61 fields · synced May 18, 2026
- EUDAMED 82717bfc-1721-4308-b505-362ff780cb2f 61 fields · synced May 18, 2026
- EUDAMED 680761b7-a07e-4dd3-b282-8ecff7f69ba8 61 fields · synced May 19, 2026
- EUDAMED f4dcb073-5fcf-4122-ac9e-45d06342c3b3 61 fields · synced May 19, 2026
- EUDAMED bf61b53e-7ca4-4410-bf04-6d7d3ace97c9 61 fields · synced May 19, 2026
- EUDAMED 36e7c93d-c21b-4e97-81f2-d54fe2cb30bc 61 fields · synced May 19, 2026
- EUDAMED 06214599-fe7a-495a-95ce-f6067707b587 61 fields · synced May 19, 2026
- EUDAMED 5f9c475b-105f-4a48-a3df-aaea25fec9db 61 fields · synced May 19, 2026
- EUDAMED 3dd46862-a663-40b9-bea9-ea681e85b710 61 fields · synced May 19, 2026
- EUDAMED 86707541-dc49-4688-a7cc-074fae07937b 61 fields · synced May 19, 2026
- EUDAMED 04a1278e-1512-4ce0-bfa7-bc5eefb9c08a 61 fields · synced May 19, 2026
- EUDAMED 0707bef9-a58b-448d-ac1b-76bd0bbbfdaa 61 fields · synced May 19, 2026
- EUDAMED 17fee882-3de0-4fbf-86f9-77b24c43f5e2 61 fields · synced May 19, 2026