Identity
- Trade Name
- Biocomma EUDAMED
- Device Name
- Disposable Swab EUDAMED
- Model / Reference
- RZS-01-01 EUDAMEDRZS-01-01a EUDAMED
Identifiers
- Primary DI / UDI-DI
- 16974660730809 EUDAMED
- Basic UDI-DI
- 697466073RZSZSP068E 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
No
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 — listed in EUDAMED — regulatory data on deviCERTS
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Also classified as General-purpose absorbent tip applicator/swab, single-use.
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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 | 697466073RZSZSP068E | Class I | 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 (1)
- EUDAMED 27839231-0734-4c01-8784-9d9533e0332d 61 fields · synced Jun 18, 2026