Identity
- Trade Name
- Biocomma EUDAMED
- Device Name
- Disposable Swabs EUDAMED
- Model / Reference
- MFS-01-01 EUDAMEDMFS-01-01植绒采样拭子 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 16974660730632 EUDAMED
- Basic UDI-DI
- B-16974660730632 EUDAMED697466073MFSZSP06SQ EUDAMED
- EMDN Code
- A1101 SAMPLE COLLECTION NEUTRAL SWABS EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Spain 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
Yes
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
Yes
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Category: General-purpose absorbent tip applicator/swab, single-use
Biocomma by Biocomma Limited — Class I — MDR, MDD — listed in EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as General-purpose absorbent tip applicator/swab, single-use.
- Disposable Sterile Swabs — Hangzhou Yiguoren Biotechnology Co.,Ltd. · Class I
- NATIONAL HOSPITAL PACKAGING — Surgi-Pak, Inc. · Class I
- Disposable Collection Tubes of Virus Samples — Jiangsu Mole Bioscience Co., LTD. · Class A
- ESCOB. PS FLOCK NASOF. 80MM EN TUBO — Deltalab, S.L. · Class IIa
- Disposable sampling swab — Jiangsu HanHeng Medical Technology Co., Ltd. · Class I
- Microbrush — YOUNG MICROBRUSH LLC · Class I
- CITOTEST — CITOTEST LABWARE MANUFACTURING CO.,LTD · Class I
- ESCOB.FLOCK NASOF. 80MM FLOW — Deltalab, S.L. · Class I
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | B-16974660730632 | Class I | Active |
| EUDAMED | European Union | CE/MDD | B-16974660730632 | Class I | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Biocomma Limited
- EUDAMED SRN
- CN-MF-000013631
- Authorised Representative
- CMC Medical Devices & Drugs SL ES-AR-000000293
Sources (2)
- EUDAMED 28603a76-9bdd-4ee4-95a4-354e641515e4 61 fields · synced Jul 26, 2026
- EUDAMED e9d204d1-19f9-43ef-b445-cacf47166908 61 fields · synced May 18, 2026