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Multienzyme cleaning agent
EUDAMEDClass I (EU MDR)
Ref Endoscopy-SpecificModel (All-Purpose, Endoscopy-Specific, Laparoscopy-Specific, Neutral, Alkaline, Dental-Specific)Ref Dental-Specific
Identity
- Device Name
- Multienzyme cleaning agent EUDAMED
- Model / Reference
- (All-Purpose, Endoscopy-Specific, Laparoscopy-Specific, Neutral, Alkaline, Dental-Specific) EUDAMEDEndoscopy-Specific EUDAMEDDental-Specific EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06971085850016 EUDAMED06971085850054 EUDAMED
- Basic UDI-DI
- 697108585MULTIENZYMEER EUDAMED
- EMDN Code
- D0801 ENZYMATIC DETERGENTS FOR MEDICAL DEVICES EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Austria 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
Multienzyme cleaning agent by Hebei Ruihan Medical Equipment Technology Co., Ltd — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Medical device disinfection agent.
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- 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 | 697108585MULTIENZYMEER | Class I | Active |
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Manufacturer
- Manufacturer
- Hebei Ruihan Medical Equipment Technology Co., Ltd
- EUDAMED SRN
- CN-MF-000048839
- Authorised Representative
- SUNGO Europe B.V. NL-AR-000000247
Sources (2)
- EUDAMED f54429ec-48b1-4757-a930-c2200dff03d9 61 fields · synced Jul 31, 2026
- EUDAMED 818113d9-1e1e-4983-a5cb-c74238d793b1 61 fields · synced May 18, 2026