Identity
- Trade Name
- R01020102 EUDAMED
- Device Name
- Laryngeal Mask Airway EUDAMED
- Model / Reference
- LMA1004P2 EUDAMED
Identifiers
- Primary DI / UDI-DI
- D-LMA1004P2TF EUDAMED
- Basic UDI-DI
- B-LMA1004P2TF EUDAMED
- EMDN Code
- R01020102 LARYNGEAL MASKS, DOUBLE-LUMEN EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Germany 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
Category: Laryngeal mask airway, single-use
R01020102 by Hangzhou Tappa Medical Technology Co , Ltd. — Class IIa — MDD — listed in EUDAMED — regulatory data on deviCERTS
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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-LMA1004P2TF | Class IIa | Active |
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Manufacturer
- Manufacturer
- Hangzhou Tappa Medical Technology Co , Ltd.
- EUDAMED SRN
- CN-MF-000027753
- Authorised Representative
- Prolinx GmbH DE-AR-000005129
Sources (1)
- EUDAMED 2acc46f8-51f2-49c4-bcc6-f11681735295 61 fields · synced Jul 28, 2026