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Spictra
EUDAMEDClass IIa (EU MDR)
Ref SPT-CK-03/2025-09Model MMM Non CoronaryModel KMCH HOSPITAL ADULT - A PACK Model STANLY HOSPITAL ADULT PACK Model Cardioplegia Tubing Set(531/v1)Ref M23MPModel Myocardial Protection System M23MPModel MHF - NEONATAL DOUBLE VENOUS-CTB-MHBModel MHF Semi Adult Single Venous LineRef M7C-AdultRef M7PBModel Bubble Trap-Pead W/o LoopModel 1/4 PVC Tubing (12 Feet)Model Sparsh Hospital-Adult-BModel NIZAM'S INSTITUTE HYD ADULT PACKRef M4CRef M20MPModel Myocardial Protection System - M20MPRef 06/2020Model JJ Hosp Cpack-Adult W/ABFRef M7ABModel Adult with loopRef M8CPModel 2 literRef M17MPModel Myocardial Protection System Adult W/o RtModel TNMSSH 1/2 PUMB HEAD.Model ADULT MODIFIED PERFUSION PACK
Identity
- Trade Name
- SPICTRA EUDAMED
- Device Name
- Perfusion Custom Pack EUDAMEDMyocaridal Protection System EUDAMEDCardiotomy Reservoir 2000 ml EUDAMEDBubble Trap EUDAMEDCardiotomy Reservoir 3000 ml EUDAMEDMyocardial protection system EUDAMEDBubble Trap-Adult with Loop EUDAMEDCardioplegia Delivery System EUDAMED
- Model / Reference
- MMM Non Coronary EUDAMEDSPT-CK-03/2025-09 EUDAMEDKMCH HOSPITAL ADULT - A PACK EUDAMEDSTANLY HOSPITAL ADULT PACK EUDAMEDCardioplegia Tubing Set(531/v1) EUDAMEDMyocardial Protection System M23MP EUDAMEDM23MP EUDAMEDMHF - NEONATAL DOUBLE VENOUS-CTB-MHB EUDAMEDMHF Semi Adult Single Venous Line EUDAMEDM7C-Adult EUDAMEDBubble Trap-Pead W/o Loop EUDAMEDM7PB EUDAMED1/4 PVC Tubing (12 Feet) EUDAMEDSparsh Hospital-Adult-B EUDAMEDNIZAM'S INSTITUTE HYD ADULT PACK EUDAMEDM4C EUDAMEDMyocardial Protection System - M20MP EUDAMEDM20MP EUDAMEDJJ Hosp Cpack-Adult W/ABF EUDAMED06/2020 EUDAMEDAdult with loop EUDAMEDM7AB EUDAMED2 liter EUDAMEDM8CP EUDAMEDMyocardial Protection System Adult W/o Rt EUDAMEDM17MP EUDAMEDTNMSSH 1/2 PUMB HEAD. EUDAMEDADULT MODIFIED PERFUSION PACK EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08906172230417 EUDAMED08906172230691 EUDAMED08906172230677 EUDAMED08906172230530 EUDAMED08906172230097 EUDAMED08906172230721 EUDAMED08906172230622 EUDAMED08906172230011 EUDAMED08906172230196 EUDAMED08906172230561 EUDAMED08906172230639 EUDAMED08906172230714 EUDAMED08906172230028 EUDAMED08906172230073 EUDAMED08906172230455 EUDAMED08906172230158 EUDAMED08906172230035 EUDAMED08906172230066 EUDAMED08906172230424 EUDAMED08906172230554 EUDAMED
- Basic UDI-DI
- B-08906172230417 EUDAMEDB-08906172230691 EUDAMEDB-08906172230677 EUDAMEDB-08906172230530 EUDAMEDB-08906172230097 EUDAMEDB-08906172230721 EUDAMEDB-08906172230622 EUDAMEDB-08906172230011 EUDAMEDB-08906172230196 EUDAMEDB-08906172230561 EUDAMEDB-08906172230639 EUDAMEDB-08906172230714 EUDAMEDB-08906172230028 EUDAMEDB-08906172230073 EUDAMEDB-08906172230455 EUDAMEDB-08906172230158 EUDAMEDB-08906172230035 EUDAMEDB-08906172230066 EUDAMEDB-08906172230424 EUDAMEDB-08906172230554 EUDAMED
- EMDN Code
- C03010101 EXTRACORPOREAL CIRCULATION CIRCUITS EUDAMEDC030102 CARDIOPLEGIA SOLUTION ADMINISTRATION KITS EUDAMEDC03010104 EXTRACORPOREAL CIRCULATION FILTERS EUDAMEDC03010102 OXYGENATOR KITS EUDAMED
Classification
- Device Class
- Class IIa 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
Spictra by Medihub Sciencetec Private Limited — Class IIa — MDD — listed in EUDAMED — regulatory data on deviCERTS
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-08906172230417 | Class IIa | Active |
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Manufacturer
- Manufacturer
- Medihub Sciencetec Private Limited
- EUDAMED SRN
- IN-MF-000007056
- Authorised Representative
- Meddevices Lifesciences B.V. NL-AR-000000594
Sources (20)
- EUDAMED dabe38b8-4ea1-4926-8724-62d961b24a27 61 fields · synced Aug 3, 2026
- EUDAMED 9d8a275f-7dec-4b62-9fb6-9a2cb5a5c1d1 61 fields · synced May 17, 2026
- EUDAMED 7c56c9ff-6749-46dc-88ff-2d725c82430b 61 fields · synced May 17, 2026
- EUDAMED e28983d1-f6a8-4834-9fed-705693cc570e 61 fields · synced May 17, 2026
- EUDAMED b5f5a93f-0964-42c1-9165-7d10ad55ea46 61 fields · synced May 17, 2026
- EUDAMED a4abedd5-84be-4699-9726-76092c74761c 61 fields · synced May 17, 2026
- EUDAMED a0dbcf4a-c255-41ad-be3a-3dc7561df160 61 fields · synced May 17, 2026
- EUDAMED 05f0c53f-5e3d-4c07-bbd5-0613dd27753f 61 fields · synced May 17, 2026
- EUDAMED dc26c4c6-0604-4b70-81f9-f67d94da708f 61 fields · synced May 17, 2026
- EUDAMED a1bddf58-fb06-4651-9980-5cd8e39384d5 61 fields · synced May 17, 2026
- EUDAMED 12df537f-c4ed-48b7-ab40-3b6e3d5febc1 61 fields · synced May 17, 2026
- EUDAMED 5c62290a-57ab-46db-bb25-532fa9f959bc 61 fields · synced May 17, 2026
- EUDAMED e7823120-1b81-41a7-9cb6-9107affcb941 61 fields · synced May 17, 2026
- EUDAMED 9592f3b8-2dff-4057-ba29-b13b7f304885 61 fields · synced May 18, 2026
- EUDAMED 92cadd7b-87d3-482f-99a6-5393d3c38f93 61 fields · synced May 18, 2026
- EUDAMED 7c147085-b334-46e9-95c1-080a725b6985 61 fields · synced May 18, 2026
- EUDAMED 4fab08d4-47cc-4244-bfdb-431061052611 61 fields · synced May 18, 2026
- EUDAMED 34e34fb6-9771-41c6-a085-84078b834d46 61 fields · synced May 18, 2026
- EUDAMED 27e5f599-992a-40fb-8727-d0850e04b678 61 fields · synced May 19, 2026
- EUDAMED e3f3175a-759f-4d06-85df-ee677f159b58 61 fields · synced May 19, 2026