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Biocomma
EUDAMEDClass A (EU MDR)
Ref XSB001ERef CJ005-36-03Model CJ005-36-01Ref Type B (bone marrow)10mlModel Type B (bone marrow)Ref MFS-01-01aModel MFS-01-01Ref XSB004ERef NAES-N96Ref Type B (bone marrow)1mlRef MFS-01-03Ref 50pcs/boxModel YVJRef CJ005-100-01Ref RZS-01-01Ref MFS-02-01fRef NAES-DC96Ref YMJRef Type B (bone marrow)7mlRef CJ005-100-04Ref Type B (bone marrow)8mlRef Type B (contain preservation medium)Model Type A (contain preservation medium)Ref MFS-02-01Ref NAES-96PlusModel NAES-96Plus Ref CJ005-50-04Ref Type B (bone marrow)9mlRef Type A Ref CJ005-50-02Ref XSB002ERef Type B (bone marrow)3mlRef CJ005-50-01Ref Type B (bone marrow)6mlRef Type A (peripheral blood)2mlModel Type A(peripheral blood)Ref XSB003ERef CJ005-100-03Ref CC01EModel CC01E Ref Type A (peripheral blood)8mlRef Type A (peripheral blood) 6mlRef Type A (peripheral blood)4ml
Identity
- Trade Name
- Biocomma EUDAMED
- Device Name
- Neonatal Screening Cards EUDAMEDCell Preservation Solution EUDAMEDCell Culture Media EUDAMEDDisposable Swabs EUDAMEDNucleic Acid Extraction System EUDAMEDDisposable Swab EUDAMEDTransport and preservation medium EUDAMEDAutomated Sample Preparation System EUDAMEDSaliva Collectors EUDAMEDCell Culture Medium EUDAMEDCollection Card EUDAMED
- Model / Reference
- XSB001E EUDAMEDCJ005-36-01 EUDAMEDCJ005-36-03 EUDAMEDType B (bone marrow) EUDAMEDType B (bone marrow)10ml EUDAMEDMFS-01-01 EUDAMEDMFS-01-01a EUDAMEDXSB004E EUDAMEDNAES-N96 EUDAMEDType B (bone marrow)1ml EUDAMEDMFS-01-03 EUDAMEDYVJ EUDAMED50pcs/box EUDAMEDCJ005-100-01 EUDAMEDRZS-01-01 EUDAMEDMFS-02-01f EUDAMEDNAES-DC96 EUDAMEDYMJ EUDAMEDType B (bone marrow)7ml EUDAMEDCJ005-100-04 EUDAMEDType B (bone marrow)8ml EUDAMEDType A (contain preservation medium) EUDAMEDType B (contain preservation medium) EUDAMEDMFS-02-01 EUDAMEDNAES-96Plus EUDAMEDCJ005-50-04 EUDAMEDType B (bone marrow)9ml EUDAMEDType A EUDAMEDCJ005-50-02 EUDAMEDXSB002E EUDAMEDType B (bone marrow)3ml EUDAMEDCJ005-50-01 EUDAMEDType B (bone marrow)6ml EUDAMEDType A(peripheral blood) EUDAMEDType A (peripheral blood)2ml EUDAMEDXSB003E EUDAMEDCJ005-100-03 EUDAMEDCC01E EUDAMEDType A (peripheral blood)8ml EUDAMEDType A (peripheral blood) 6ml EUDAMEDType A (peripheral blood)4ml EUDAMED
Identifiers
- Primary DI / UDI-DI
- 16974660730267 EUDAMED16974660730342 EUDAMED06974660730611 EUDAMED16974660730649 EUDAMED16974660730298 EUDAMED06974660730154 EUDAMED06974660730529 EUDAMED16974660730779 EUDAMED16974660730236 EUDAMED16974660730311 EUDAMED16974660730793 EUDAMED16974660730724 EUDAMED06974660730178 EUDAMED16974660730243 EUDAMED06974660730581 EUDAMED16974660730373 EUDAMED06974660730598 EUDAMED16974660730212 EUDAMED16974660730663 EUDAMED06974660730147 EUDAMED16974660730410 EUDAMED06974660730604 EUDAMED16974660730199 EUDAMED16974660730397 EUDAMED16974660730274 EUDAMED06974660730536 EUDAMED06974660730543 EUDAMED16974660730380 EUDAMED06974660730574 EUDAMED06974660730437 EUDAMED16974660730281 EUDAMED16974660730359 EUDAMED06974660730185 EUDAMED06974660730499 EUDAMED06974660730475 EUDAMED06974660730451 EUDAMED
- Basic UDI-DI
- 697466073XSEP05YE EUDAMED697466073P10RY EUDAMED697466073BP15LB EUDAMED697466073MFSZSP06SQ EUDAMED697466073NAESN96P04G2 EUDAMED697466073MFSTGP06N2 EUDAMED697466073YVJP012S EUDAMED697466073RZSZSP068E EUDAMED697466073NAESDC96P173C EUDAMED697466073YMJP01XL EUDAMED697466073P07SB EUDAMED697466073NAES96PP04CC EUDAMED697466073AP15L4 EUDAMED697466073P05S7 EUDAMED
- Direct Marketing DI
- 06974660730611 EUDAMED06974660730154 EUDAMED06974660730529 EUDAMED16974660730236 EUDAMED06974660730178 EUDAMED06974660730581 EUDAMED06974660730598 EUDAMED16974660730212 EUDAMED06974660730147 EUDAMED06974660730604 EUDAMED16974660730199 EUDAMED06974660730536 EUDAMED06974660730543 EUDAMED06974660730574 EUDAMED06974660730437 EUDAMED06974660730185 EUDAMED06974660730499 EUDAMED06974660730475 EUDAMED06974660730451 EUDAMED
- EMDN Code
- W0501010202 CAPILLARY AND VENOUS BLOOD COLLECTION, INTEGRATED SYSTEMS EUDAMEDW050299 DEVICES FOR SAMPLES TRANSPORT - OTHER EUDAMEDW0104010203 TRANSPORT MEDIA EUDAMEDA1101 SAMPLE COLLECTION NEUTRAL SWABS EUDAMEDW02050116 NUCLEIC ACID TESTING INTEGRATED EXTRACTION /AMPLIFICATION /DETECTION SYSTEMS EUDAMEDA1102 SAMPLE COLLECTION SWABS WITH TRANSPORT MEDIUM EUDAMEDW02060102 AUTOMATED SAMPLE TRANSPORT SYSTEMS EUDAMEDW05020104 SAMPLES TRANSPORT, VASES EUDAMED
Classification
- Device Class
- Class A EUDAMEDClass I EUDAMED
- Market of Registration
- Spain EUDAMED
Clinical & Handling
Sterile
No
EUDAMEDEUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
Yes
EUDAMEDEUDAMED
Animal Tissues
No
EUDAMED
Microbial Substances
No
EUDAMEDEUDAMED
Endocrine Disruptor
No
EUDAMED
Reagent
Yes
EUDAMEDEUDAMED
Self Testing
No
EUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMEDEUDAMED
Administering Medicine
Yes
EUDAMED
Measuring Function
No
EUDAMED
Surgical Instrument
No
EUDAMEDEUDAMED
New Device
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Biocomma by Biocomma Limited — Class A — IVDR, MDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/IVDR
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDR | 697466073XSEP05YE | Class A | Active |
| EUDAMED | European Union | CE/MDR | 697466073XSEP05YE | Class A | Active |
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Manufacturer
- Manufacturer
- Biocomma Limited
- EUDAMED SRN
- CN-MF-000013631
- Authorised Representative
- CMC Medical Devices & Drugs SL ES-AR-000000293
Sources (36)
- EUDAMED 0ee15e17-e24f-40c0-a85e-b3f9180a4d4b 61 fields · synced Aug 1, 2026
- EUDAMED ccdc805e-4208-49c7-aeed-1832a053b0c0 61 fields · synced May 16, 2026
- EUDAMED fb275ddb-2ae5-4132-af09-9276ed4b9242 61 fields · synced May 16, 2026
- EUDAMED 3d505e7e-33d4-48e3-9204-9a92b809ff14 61 fields · synced May 17, 2026
- EUDAMED 33d91ee5-4718-4f5a-be76-1a0c31139ab6 61 fields · synced May 17, 2026
- EUDAMED 968aea0c-b74d-4155-a6a3-80b5a742be27 61 fields · synced May 17, 2026
- EUDAMED 78b21083-4f25-4217-a8cb-113996a32f1f 61 fields · synced May 17, 2026
- EUDAMED 5853b995-0b66-4a05-9ea3-5968e775f3e1 61 fields · synced May 17, 2026
- EUDAMED 0a283271-5a3f-4b07-a4a1-728584c53f35 61 fields · synced May 17, 2026
- EUDAMED 6e2e86c0-f9e7-4bfd-8a2f-ca9869ab2869 61 fields · synced May 17, 2026
- EUDAMED c87d16a7-b3b9-4677-b58a-12605d7f052f 61 fields · synced May 17, 2026
- EUDAMED 4d45a13d-449b-410c-a418-5b0676cb3bc4 61 fields · synced May 17, 2026
- EUDAMED 470b3bb1-6ec5-4776-995f-2f8f430ada67 61 fields · synced May 17, 2026
- EUDAMED 31d164a6-0cde-4077-a4f4-9f2de43aa59d 61 fields · synced May 17, 2026
- EUDAMED 836a0dcb-5d68-4f9b-af6a-eb64fdce66c7 61 fields · synced May 17, 2026
- EUDAMED 2c20e0f6-eb7d-4823-be0b-f0de294098e0 61 fields · synced May 17, 2026
- EUDAMED 14dee230-2f11-4fbe-81f6-aecf05a21327 61 fields · synced May 17, 2026
- EUDAMED 46e89783-009b-4215-ba06-193bdbc4f95f 61 fields · synced May 17, 2026
- EUDAMED 67d6aa63-4050-4417-9324-f26cd255bc3d 61 fields · synced May 18, 2026
- EUDAMED 34a9536a-ed58-4f5c-8b10-920757fe1ead 61 fields · synced May 18, 2026
- EUDAMED 793197f4-c2ff-4689-872d-d380345a76b3 61 fields · synced May 18, 2026
- EUDAMED ee75bb43-b28f-446d-8237-57d6a3153705 61 fields · synced May 18, 2026
- EUDAMED ca05cc1c-dd18-4181-95d6-a9a93bf9ad08 61 fields · synced May 18, 2026
- EUDAMED 989fc7e9-56c5-491f-ac78-b7e820b6a1b4 61 fields · synced May 18, 2026
- EUDAMED 7f6277a9-4e8d-4f3e-9c81-e515c457d2e6 61 fields · synced May 18, 2026
- EUDAMED 63875389-1067-42cf-82fe-97ba18afdbde 61 fields · synced May 18, 2026
- EUDAMED 593f3288-0519-418e-bd68-d42f6d39dd0a 61 fields · synced May 18, 2026
- EUDAMED fe8ef759-19f8-451e-bf79-20974693f107 61 fields · synced May 18, 2026
- EUDAMED e37c08e3-3073-42bf-b84b-4e4868a64568 61 fields · synced May 18, 2026
- EUDAMED 98e48901-ebb3-4f7b-a012-36c8baa6b3d9 61 fields · synced May 18, 2026
- EUDAMED 70faa6ca-5099-44e9-975d-b7271a6702da 61 fields · synced May 18, 2026
- EUDAMED 0562404d-f0b8-4929-b79f-b285b3d78950 61 fields · synced May 18, 2026
- EUDAMED 7fec4070-4385-4d94-a75b-befae3dcf186 61 fields · synced May 19, 2026
- EUDAMED 998eee9c-a07c-4703-8511-08fc20b65c8e 61 fields · synced May 19, 2026
- EUDAMED 0ff1a376-29dd-4014-98e3-43ba6a302ae2 61 fields · synced May 19, 2026
- EUDAMED 57652797-53a0-43a1-b307-1f56dacb9ace 61 fields · synced May 19, 2026