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Hollow Fiber Dialyzer
EUDAMEDClass IIb (EU MDR)
Ref TCD0110Model F10, F12, F13, F14, F15, F16, F17, F18, F19, F20, HF10, HF12, HF13, HF14, HF15, HF16, HF17, HF18, HF19, HF20, HF21, HF22, HF23, MF10, MF12, MF13, MF14, MF15, MF16, MF17, MF18, MF19, E15H, E16H, E17H, E18H, E19H, E20H, E21H, E22H, E23HRef TCG0116Ref TCG0114Ref TCG0217Ref TCZ0113Ref TCG0117Ref TCG0220Ref TCD0120Ref TCD0113Ref TPZ0124Model MF150, MF160,MF170,MF180,MF190,MF200,MF210,MF220,MF230,MF240 HF150,HF160,HF170,HF180,HF190,HF200,HF210,HF220,,HF230,HF240Ref TCZ0117Ref TCG0223Ref TCZ0112Ref TCG0119Ref TPZ0117Ref TCG0221Ref TCG0218Ref TPZ0119Ref TCG0215Ref TPZ0121Ref TPG0116Ref TPG0115Ref TCG0110Ref TPZ0122Ref TCD0118Ref TCD0114Ref TCG0122Ref TCZ0118
Identity
- Trade Name
- Hollow Fiber Dialyzer EUDAMED
- Device Name
- Hollow Fiber Dialyzer EUDAMED
- Model / Reference
- F10, F12, F13, F14, F15, F16, F17, F18, F19, F20, HF10, HF12, HF13, HF14, HF15, HF16, HF17, HF18, HF19, HF20, HF21, HF22, HF23, MF10, MF12, MF13, MF14, MF15, MF16, MF17, MF18, MF19, E15H, E16H, E17H, E18H, E19H, E20H, E21H, E22H, E23H EUDAMEDTCD0110 EUDAMEDTCG0116 EUDAMEDTCG0114 EUDAMEDTCG0217 EUDAMEDTCZ0113 EUDAMEDTCG0117 EUDAMEDTCG0220 EUDAMEDTCD0120 EUDAMEDTCD0113 EUDAMEDMF150, MF160,MF170,MF180,MF190,MF200,MF210,MF220,MF230,MF240 HF150,HF160,HF170,HF180,HF190,HF200,HF210,HF220,,HF230,HF240 EUDAMEDTPZ0124 EUDAMEDTCZ0117 EUDAMEDTCG0223 EUDAMEDTCZ0112 EUDAMEDTCG0119 EUDAMEDTPZ0117 EUDAMEDTCG0221 EUDAMEDTCG0218 EUDAMEDTPZ0119 EUDAMEDTCG0215 EUDAMEDTPZ0121 EUDAMEDTPG0116 EUDAMEDTPG0115 EUDAMEDTCG0110 EUDAMEDTPZ0122 EUDAMEDTCD0118 EUDAMEDTCD0114 EUDAMEDTCG0122 EUDAMEDTCZ0118 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 56947793310338 EUDAMED56947793305877 EUDAMED56947793303064 EUDAMED56947793306348 EUDAMED56947793310123 EUDAMED56947793309080 EUDAMED56947793306379 EUDAMED56947793304122 EUDAMED56947793304467 EUDAMED56947793303811 EUDAMED56947793310130 EUDAMED56947793306409 EUDAMED56947793310116 EUDAMED56947793300636 EUDAMED56947793308892 EUDAMED56947793306386 EUDAMED56947793306355 EUDAMED56947793308915 EUDAMED56947793306324 EUDAMED56947793308939 EUDAMED56947793308809 EUDAMED56947793308793 EUDAMED56947793304337 EUDAMED56947793308946 EUDAMED56947793304283 EUDAMED56947793304306 EUDAMED56947793304566 EUDAMED56947793304153 EUDAMED
- Basic UDI-DI
- 69477933Dialyzer019J EUDAMED69477933Dialyzer029L EUDAMED
- Unit of Use DI
- 06947793310333 EUDAMED06947793305872 EUDAMED06947793303069 EUDAMED06947793306343 EUDAMED06947793310128 EUDAMED06947793309085 EUDAMED06947793306374 EUDAMED06947793304127 EUDAMED06947793304462 EUDAMED06947793303816 EUDAMED06947793310135 EUDAMED06947793306404 EUDAMED06947793310111 EUDAMED06947793300631 EUDAMED06947793308897 EUDAMED06947793306381 EUDAMED06947793306350 EUDAMED06947793308910 EUDAMED06947793306329 EUDAMED06947793308934 EUDAMED06947793308804 EUDAMED06947793308798 EUDAMED06947793304332 EUDAMED06947793308941 EUDAMED06947793304288 EUDAMED06947793304301 EUDAMED06947793304561 EUDAMED06947793304158 EUDAMED
- EMDN Code
- F01060103 DIALYSERS - UFC < 18 ml/h/mmHg, SYNTHETIC MEMBRANES EUDAMEDF01060303 DIALYSERS - UFC > 35 ml/h/mmHg, SYNTHETIC MEMBRANES EUDAMEDF01060203 DIALYSERS - UFC = 18 - 35 ml/h/mmHg, SYNTHETIC MEMBRANES EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- Poland EUDAMEDGermany EUDAMED
Clinical & Handling
Sterile
Yes
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
Yes
EUDAMEDEUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Hollow Fiber Dialyzer by Shandong Weigao Blood Purification Products Co., Ltd. — Class IIb — MDR — listed in EUDAMED — regulatory data on deviCERTS
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 | 69477933Dialyzer019J | Class IIb | Active |
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Manufacturer
- EUDAMED SRN
- CN-MF-000012203
- Authorised Representative
- MedNet EC-REP C IIb GmbH DE-AR-000011194
Sources (28)
- EUDAMED 26ff675d-12e0-48c0-a548-3e2b6a9d9548 61 fields · synced Oct 6, 2026
- EUDAMED cf830ace-f82f-4565-bdfd-8527a47032aa 61 fields · synced Jun 18, 2026
- EUDAMED a2c864f5-af4b-4d3c-907a-ee442bee88f3 61 fields · synced Jul 9, 2026
- EUDAMED 1f32371f-7784-45ab-9907-6a99bb621d42 61 fields · synced Jul 9, 2026
- EUDAMED 174f845c-9558-43d1-b4af-01395299d1c0 61 fields · synced Jul 9, 2026
- EUDAMED 5848c37c-cdaa-4634-8f52-bddde5893bd3 61 fields · synced Jul 10, 2026
- EUDAMED 03296874-b6b9-4e14-a108-de4ed00616c4 61 fields · synced Jul 10, 2026
- EUDAMED 13aa4dff-fb21-49a8-9a00-5d3330e43d06 61 fields · synced Jul 11, 2026
- EUDAMED 8b5ca4a2-8ba6-42fc-a597-5e15ef18b6fc 61 fields · synced Jul 11, 2026
- EUDAMED b7ed2208-50c2-4ee7-809d-77e7d16682d1 61 fields · synced Jul 12, 2026
- EUDAMED 27157469-09db-4a05-bdac-b2a9562ede7a 61 fields · synced Jul 12, 2026
- EUDAMED 4f2296e9-cea8-488e-8a15-0c3cde8fa8ad 61 fields · synced Jul 12, 2026
- EUDAMED 145e5e23-f1c1-4273-8e94-3647de8dd632 61 fields · synced Jul 13, 2026
- EUDAMED a9265e9b-5b45-4eb6-aa98-b630166fb6f4 61 fields · synced Jul 16, 2026
- EUDAMED 952b0c0b-ac1b-4c67-bc0e-bbed5b88d2ad 61 fields · synced Jul 16, 2026
- EUDAMED 09165a27-9035-4dea-bccb-4aae5b737849 61 fields · synced Jul 17, 2026
- EUDAMED 3e2fa87f-ae5a-4041-bea8-5cdc63bf987d 61 fields · synced Jul 19, 2026
- EUDAMED f470b13c-0c6a-478d-b886-5b0a8f589f8a 61 fields · synced Jul 21, 2026
- EUDAMED 92a54f06-d0a0-4cd6-9064-aeffc9d99b26 61 fields · synced Jul 21, 2026
- EUDAMED 36ec86f7-ae2c-41b1-b594-4565927039a5 61 fields · synced Jul 23, 2026
- EUDAMED a13306d5-c848-4222-b16b-8386f9124d86 61 fields · synced Jul 25, 2026
- EUDAMED 2a4660f3-92ff-4e1a-af18-740a9152ef03 61 fields · synced Jul 27, 2026
- EUDAMED 0b789d88-9f96-491e-9411-904368495148 61 fields · synced Jul 28, 2026
- EUDAMED dcad6bdf-5b76-4c88-a9c3-4a39bbbee387 61 fields · synced Jul 31, 2026
- EUDAMED e6e01317-44a1-4458-abed-5785e77ce7a4 61 fields · synced Jul 31, 2026
- EUDAMED 3f2eccaf-8ca9-44c3-b750-f1325b5abcdc 61 fields · synced Aug 1, 2026
- EUDAMED f5dd8807-1294-42d3-a46c-4a05cd90d355 61 fields · synced Aug 1, 2026
- EUDAMED 126b5147-8a71-4251-b68c-8ae9a562d4fd 61 fields · synced Aug 3, 2026