CouchStrip CS50FCF-S
FDA UDIEUDAMEDClass II (US FDA UDI)
Identity
- Trade Name
- CouchStrip CS50FCF-S FDA UDICouchStrip CS50FCF-EX FDA UDI
- Generic Name
- Indexed-immobilization patient positioning system FDA UDI
- Device Name
- CouchStrip EUDAMEDCouchStrip with sliding sidepieces for 50 cm wide couchtops, fixed, carbon fiber, 2P FDA UDICouchStrip with Exact sidepieces for 50 cm wide couchtops, fixed, carbon fiber, 2P FDA UDI
- Model / Reference
- 147140 EUDAMED147170 EUDAMED147420 EUDAMED147310 EUDAMED147630 EUDAMED147440 EUDAMED147270 EUDAMED164170 EUDAMED147680 EUDAMED147350 EUDAMED147450 EUDAMED147640 EUDAMED147950 EUDAMED147670 EUDAMED147390 EUDAMED147460 EUDAMED147660 EUDAMED147370 EUDAMEDCS50FCF-S FDA UDICS50FCF-EX FDA UDI
- Description
- CouchStrip with sliding sidepieces for 50 cm wide couchtops, fixed, carbon fiber, 2P FDA UDICouchStrip with Exact sidepieces for 50 cm wide couchtops, fixed, carbon fiber, 2P FDA UDI
Identifiers
- Catalog Number
- 147140 FDA UDI147950 FDA UDI
- Primary DI / UDI-DI
- 08720168160324 EUDAMEDFDA UDI08719425705606 EUDAMEDFDA UDI08719425707358 EUDAMED08720168163554 EUDAMED08720168163219 EUDAMED08720168163684 EUDAMED08720168163578 EUDAMED08720168160959 EUDAMED08719425707532 EUDAMED08720168163653 EUDAMED08720168161994 EUDAMED08720168163585 EUDAMED08720168163691 EUDAMED08720168163639 EUDAMED08720168162311 EUDAMED08720168163592 EUDAMED08720168163707 EUDAMED08720168163523 EUDAMED
- Basic UDI-DI
- 872016816147100JV EUDAMED
- FDA Product Code
- IYE FDA UDI
- EMDN Code
- Z12011280 PATIENT POSITIONING INSTRUMENTS - HARDWARE ACCESSORIES EUDAMED
- GMDN Term
- Indexed-immobilization patient positioning system FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 892.5050 FDA UDI
- Market of Registration
- Northern Ireland EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
Single Use
No
Implantable
No
Reusable
No
Contains Latex
No
Reprocessed
No
CMR Substance
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
Prescription Use
Yes
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
No
Lot / Batch Number
No
Serial Number
Yes
Expiration Date
No
Manufacturing Date
Yes
Category: Indexed-immobilization patient positioning system
CouchStrip CS50FCF-S by Macromedics B.v. — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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Authorization Coverage (2 countries)
Regulatory Authorizations
MDR
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Macromedics B.v.
Sources (20)
- FDA UDI 20125728-523d-4ae6-8834-5d582b518cea 34 fields · synced Aug 4, 2026
- FDA UDI 5cc01de2-781c-473b-abbc-238c47951eb6 34 fields · synced May 30, 2026
- EUDAMED 13e641af-d559-4fd7-98f6-be40d297c6e1 61 fields · synced Jun 20, 2026
- EUDAMED c0bf727e-30ec-45bb-b416-e3e24e4cb24a 61 fields · synced Jun 20, 2026
- EUDAMED 9da12209-0ada-494e-8146-b7339fe026d7 61 fields · synced Jul 9, 2026
- EUDAMED d7fec63b-72be-47c9-acba-8fcfc52f2ea6 61 fields · synced Jul 9, 2026
- EUDAMED da0d9048-6c64-4fcd-8c54-cdb2c2871e17 61 fields · synced Jul 9, 2026
- EUDAMED a8fa422d-f2f3-404d-9a94-373f7af1ef67 61 fields · synced Jul 10, 2026
- EUDAMED e00a6c26-33a9-4ef3-aca9-2d585405ef14 61 fields · synced Jul 12, 2026
- EUDAMED c7a08e61-76ca-4300-bd25-16b783ecb761 61 fields · synced Jul 17, 2026
- EUDAMED cbca8f04-b1f7-4b3c-95bf-add0784e8f39 61 fields · synced Jul 20, 2026
- EUDAMED 375fe0b5-7bae-4475-ad15-71e512e14cb4 61 fields · synced Jul 21, 2026
- EUDAMED f9377c53-5f75-438b-8dab-ef8684533e39 61 fields · synced Jul 22, 2026
- EUDAMED f46559c0-b02f-4c58-827e-9671639aad1b 61 fields · synced Jul 22, 2026
- EUDAMED 27957b7f-0499-47ce-9692-cb04af7c2f0c 61 fields · synced Jul 22, 2026
- EUDAMED 915d6d34-5084-4f27-a983-836fbb5adaef 61 fields · synced Jul 23, 2026
- EUDAMED 9e7a8e20-6754-42f6-82f2-2d2ab2c80c85 61 fields · synced Jul 24, 2026
- EUDAMED a7f1ab6a-baf6-4b90-8703-8af521ee5a58 61 fields · synced Aug 2, 2026
- EUDAMED 556b87fe-5169-4d74-8ebf-68d2a507b9b6 61 fields · synced Aug 3, 2026
- EUDAMED f493e390-599a-44a9-bdd2-93dc582b8f59 61 fields · synced Aug 4, 2026