← Back to catalogue
thermosept X-tra enzymatic cleaner
EUDAMEDClass I (EU MDR)
Ref 70003120Ref 70003121Ref 70003127
Identity
- Trade Name
- thermosept X-tra enzymatic cleaner EUDAMED
- Device Name
- thermosept X-tra enzymatic cleaner EUDAMED
- Model / Reference
- 70003120 EUDAMED70003121 EUDAMED70003127 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04032651981144 EUDAMED04032651981151 EUDAMED04032651981229 EUDAMED
- Basic UDI-DI
- 4032651BSC00000062AG EUDAMED
- EMDN Code
- D0801 ENZYMATIC DETERGENTS FOR MEDICAL DEVICES EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
No
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: Medical device disinfection agent
thermosept X-tra enzymatic cleaner by Schülke & Mayr GmbH — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Medical device disinfection agent.
- Patterson® — PATTERSON DENTAL SUPPLY, INC. · Class I
- Instru Zym — Laboratorium Dr. Deppe GmbH · Class I
- Your First Enzymatic & Non-Enzymatic Sponges — BATRIK MEDICAL MANUFACTURING INC. · Class I
- Rapidzyme PR — Novapharm Research (Australia) Pty Ltd · Class IIb
- Olie Medical Performance Enzymatic 5 — Amity Limited · Class I
- Coltene Biosonic UC40 — Topdental (Products) Ltd · Class I
- Enzymatic Detergent — QUADRALENE LTD · Class I
- Enzym Med Wipes — Laboratorium Dr. Deppe GmbH · 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 | 4032651BSC00000062AG | Class I | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Schülke & Mayr GmbH
- EUDAMED SRN
- DE-MF-000005701
Sources (3)
- EUDAMED 06e54994-d890-4726-8986-765c01da2214 61 fields · synced Jul 31, 2026
- EUDAMED 74c9bf87-6e1c-45e8-96c1-84d79b5afbee 61 fields · synced May 18, 2026
- EUDAMED 1e2089a1-1235-4a1a-a4ac-87f79cd33401 61 fields · synced May 18, 2026