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Self-Cath
EUDAMEDFDA UDIClass I (EU MDR)
Ref 50455Ref 504610Ref 504500Ref 504619Ref 504629Ref 504510Ref 50467Ref 50454Ref 50461Ref 50472Ref 50475Ref 50473Ref 50462Ref 50476Ref 504530Ref 50474Ref 50468Ref 504420Ref 504630Ref 504410
Identity
- Trade Name
- Self-Cath EUDAMEDSelf-Cath Closed System FDA UDI
- Generic Name
- Single-administration urethral catheterization kit, single-use FDA UDI
- Device Name
- Self-Cath urinary intermittent drainage catheter EUDAMEDSelf-Cath Closed System Kit. Straight Tip. Unisex. Pre-lubricated Urinary Catheterization System. Contents: Coloplast Self-Cath urethral catheter FR 8, 1100 cc collection bag, 3 Povidone-Iodine swabsticks, Benzalkonium Chloride towelette, Gloves and Underpad. Rx only. FDA UDI
- Model / Reference
- 50455 EUDAMED504610 EUDAMED504500 EUDAMED504619 EUDAMED504629 EUDAMED504510 EUDAMED50467 EUDAMED50454 EUDAMED50461 EUDAMED50472 EUDAMED50475 EUDAMED50473 EUDAMED50462 EUDAMED50476 EUDAMED504530 EUDAMED50474 EUDAMED50468 EUDAMED504420 EUDAMED504630 EUDAMED504410 EUDAMED50260 FDA UDI
- Description
- Self-Cath Closed System Kit. Straight Tip. Unisex. Pre-lubricated Urinary Catheterization System. Contents: Coloplast Self-Cath urethral catheter FR 8, 1100 cc collection bag, 3 Povidone-Iodine swabsticks, Benzalkonium Chloride towelette, Gloves and Underpad. Rx only. FDA UDI
Identifiers
- Catalog Number
- 50260 FDA UDI
- Primary DI / UDI-DI
- 05708932999250 EUDAMED05708932868006 EUDAMED05708932868211 EUDAMED05701780167611 EUDAMED05701780167628 EUDAMED05708932868181 EUDAMED05708932999199 EUDAMED05708932999267 EUDAMED05708932999243 EUDAMED05708932999168 EUDAMED05708932999137 EUDAMED05708932999151 EUDAMED05708932999236 EUDAMED05708932999120 EUDAMED05708932868129 EUDAMED05708932999144 EUDAMED05708932999182 EUDAMED05708932868273 EUDAMED05708932867948 EUDAMED05708932868303 EUDAMED05708932279130 FDA UDI
- Basic UDI-DI
- 570893229782296 EUDAMED
- FDA Product Code
- FCM FDA UDI
- EMDN Code
- U01010502 NELATON CATHETERS, NON SELF-LUBRICATING EUDAMEDU01010602 TIEMANN CATHETERS, NON SELF-LUBRICATING EUDAMED
- GMDN Term
- Single-administration urethral catheterization kit, single-use FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 876.5130 FDA UDI
- Market of Registration
- Netherlands EUDAMEDPoland EUDAMEDFrance EUDAMEDIreland EUDAMEDNorthern Ireland EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
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
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
Yes
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Dimensions & Sizes
- Size
- Catheter Gauge — 8 French FDA UDICatheter Working Length — 31 Centimeter FDA UDICatheter Working Length — 12.2 Inch FDA UDI
Self-Cath by Coloplast A/S — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 570893229782296 | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Coloplast A/S
- EUDAMED SRN
- DK-MF-000025526
Sources (21)
- EUDAMED cca74206-8fdb-4d24-a62c-da7a3816e123 61 fields · synced Sep 17, 2026
- EUDAMED bed713c2-f771-47b6-80cc-f60e1e68a7c3 61 fields · synced May 17, 2026
- EUDAMED 385e02d6-ca53-49a4-ba6f-fe4e6469ca39 61 fields · synced May 17, 2026
- EUDAMED f3701b28-3fed-4853-9c61-70045127e663 61 fields · synced May 17, 2026
- EUDAMED ce86e15b-d383-4aca-8a40-3006fe353244 61 fields · synced May 17, 2026
- EUDAMED 4fd1a527-180c-4d32-94cf-53af284a8f17 61 fields · synced May 17, 2026
- EUDAMED 7cce3c41-e52c-4679-a04a-3cc17e02a64f 61 fields · synced May 17, 2026
- EUDAMED f50f64f1-cd7a-4ece-81a2-538cc4424949 61 fields · synced May 17, 2026
- EUDAMED b9fe0f36-76c1-4686-940a-4f7ac0bd75c3 61 fields · synced May 17, 2026
- EUDAMED 6f5a8555-4b68-4560-8c24-1f7f01a211e7 61 fields · synced May 17, 2026
- EUDAMED 3ef535b5-f37b-4836-9eea-0450ce24ae2b 61 fields · synced May 18, 2026
- EUDAMED 3878a0e7-d6d9-44f1-9bc6-8e65871a00d4 61 fields · synced May 18, 2026
- EUDAMED 09e6d179-be0a-4a54-b249-824da53f33a4 61 fields · synced May 18, 2026
- EUDAMED 23e79325-4a14-4029-8385-485a31da8070 61 fields · synced May 18, 2026
- EUDAMED 4169307a-24b4-466c-9ce9-46f5033e2169 61 fields · synced May 18, 2026
- FDA UDI 5be9c5f0-ac1e-49e0-b5a5-d27385e5c5fd 37 fields · synced May 29, 2026
- EUDAMED fd30e2b2-e903-4168-b6ed-e9c18a7cec34 61 fields · synced Jul 10, 2026
- EUDAMED d444cc2f-59d8-4363-8b88-e54a55a95e13 61 fields · synced Jul 15, 2026
- EUDAMED 3f8dd2fc-6fb5-43b7-9c50-da611fe7ce9b 61 fields · synced Jul 17, 2026
- EUDAMED 3e4d3708-7827-4e58-9b91-bb3bcf21af4c 61 fields · synced Jul 22, 2026
- EUDAMED 501700ac-8573-482f-9593-18539f2a4d3d 61 fields · synced Jul 26, 2026