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Tupfer
EUDAMEDClass IIa (EU MDR)
Ref MA-106-K010-042
by Toruńskie Zakłady Materiałów Opatrunkowych Spółka Akcyjna
Identity
- Trade Name
- TUPFER EUDAMED
- Device Name
- DRESSING MATERIALS - SURGICALLY INVASIVE STERILE EUDAMED
- Model / Reference
- MA-106-K010-042 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05900516049423 EUDAMED
- Basic UDI-DI
- 5900516DDBXXXXU4 EUDAMED
- EMDN Code
- M0201050101 COTTON GAUZE PADS, WITHOUT X-RAY DETECTABLE THREAD, STERILE EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Poland 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
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Category: Intranasal splint, non-biodegradable
Tupfer by Toruńskie Zakłady Materiałów Opatrunkowych Spółka Akcyjna — Class IIa — MDR — listed in EUDAMED — regulatory data on deviCERTS
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Also classified as Intranasal splint, non-biodegradable.
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- Gauze Swabs — Jiujiang HuaDa Medical Dressing Co., Ltd. · Class I
- Custom Nasal Splint — Boston Medical Products, Inc. · Class I
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 | 5900516DDBXXXXU4 | Class IIa | Active |
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Manufacturer
- EUDAMED SRN
- PL-MF-000002200
Sources (1)
- EUDAMED c9686a9a-e273-49f9-b310-d8472b65b721 61 fields · synced Jun 19, 2026