Data from EUDAMED, last updated Aug 18, 2026

Isolation gown for single use

6976128075000B3

33 references

Class I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Risk category: Class I
Manufacturer: Operating Theatre Medical (Zhijiang) Co., Ltd

Device family identification

Device name: Isolation gown for single use
: 6976128075000B3
Device model: Blue/green/yellow/white Isolation gown with elastic cuff or knitted cuff
: GS1
Version date: Apr 19, 2024

Classification

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Risk category: Class I
Status: On the market

Device characteristics

No device characteristics flagged

References by status

Manufacturer & authorised representative

Manufacturer

Name: Operating Theatre Medical (Zhijiang) Co., Ltd
: CN-MF-000038254
Country: China
Email: sherry.liu@otmedical.com

Authorised representative

Name: mono-uso nv
: BE-AR-000001322
Country: Belgium

Product	Trade name	Reference / catalog number	Primary DI The Primary DI is the main UDI-DI a manufacturer designates as the principal identifier for a device in EUDAMED. View in glossary →	Quantity	Status
Isolation gown	Isolation gown	`I001048OTM`	`06976128075005`	10	On the market
ISOLATION GOWN PPPE 40 WITH KITTED CUFF	ISOLATION GOWN PPPE 40 WITH KITTED CUFF	`I001236OTM`	`06976128075111`	10	On the market
ISOLATION GOWN PPPE 40 WITH KNITTED CUFF	ISOLATION GOWN PPPE 40 WITH KNITTED CUFF	`I001235OTM`	`06976128075104`	10	On the market
ISOLATION GOWN PPPE 40 WITH KNITTED CUFF	ISOLATION GOWN PPPE 40 WITH KNITTED CUFF	`I001171OTM`	`06976128075036`	10	On the market
ISOLATION GOWN PPPE 40 WITH KNITTED CUFF	ISOLATION GOWN PPPE 40 WITH KNITTED CUFF	`I001442OTM`	`06976128075319`	10	On the market
ISOLATION GOWN PPPE 40 WITH KNITTED CUFF	ISOLATION GOWN PPPE 40 WITH KNITTED CUFF	`I001105OTM`	`06976128075050`	10	On the market
ISOLATION GOWN PPPE 40 WITH KNITTED CUFF	ISOLATION GOWN PPPE 40 WITH KNITTED CUFF	`I001175OTM`	`06976128075074`	10	On the market
ISOLATION GOWN PPPE 40 WITH KNITTED CUFF	ISOLATION GOWN PPPE 40 WITH KNITTED CUFF	`I001440OTM`	`06976128075418`	10	On the market
ISOLATION GOWN PPPE 40 WITH KNITTED CUFF	ISOLATION GOWN PPPE 40 WITH KNITTED CUFF	`I001237OTM`	`06976128075128`	10	On the market
ISOLATION GOWN PPPE 40 WITH KNITTED CUFF	ISOLATION GOWN PPPE 40 WITH KNITTED CUFF	`I001174OTM`	`06976128075067`	10	On the market
ISOLATION GOWN PPPE 40 WITH KNITTED CUFF	ISOLATION GOWN PPPE 40 WITH KNITTED CUFF	`I001437OTM`	`06976128075388`	10	On the market
ISOLATION GOWN PPPE 40 WITH KNITTED CUFF	ISOLATION GOWN PPPE 40 WITH KNITTED CUFF	`I001240OTM`	`06976128075159`	10	On the market
ISOLATION GOWN PPPE 40 WITH KNITTED CUFF	ISOLATION GOWN PPPE 40 WITH KNITTED CUFF	`I001439OTM`	`06976128075401`	10	On the market
ISOLATION GOWN PPPE 40 WITH KNITTED CUFF	ISOLATION GOWN PPPE 40 WITH KNITTED CUFF	`I001445OTM`	`06976128075340`	10	On the market
ISOLATION GOWN PPPE 40 WITH KNITTED CUFF	ISOLATION GOWN PPPE 40 WITH KNITTED CUFF	`I001446OTM`	`06976128075357`	10	On the market
ISOLATION GOWN PPPE 40 WITH KNITTED CUFF	ISOLATION GOWN PPPE 40 WITH KNITTED CUFF	`I001173OTM`	`06976128075043`	10	On the market
ISOLATION GOWN PPPE 40 WITH KNITTED CUFF	ISOLATION GOWN PPPE 40 WITH KNITTED CUFF	`I001239OTM`	`06976128075142`	10	On the market
ISOLATION GOWN PPPE 40 WITH KNITTED CUFF	ISOLATION GOWN PPPE 40 WITH KNITTED CUFF	`I001176OTM`	`06976128075081`	10	On the market
ISOLATION GOWN PPPE 40 WITH KNITTED CUFF	ISOLATION GOWN PPPE 40 WITH KNITTED CUFF	`I001436OTM`	`06976128075371`	10	On the market
ISOLATION GOWN PPPE 40 WITH KNITTED CUFF	ISOLATION GOWN PPPE 40 WITH KNITTED CUFF	`I001447OTM`	`06976128075364`	10	On the market
ISOLATION GOWN PPPE 40 WITH KNITTED CUFF	ISOLATION GOWN PPPE 40 WITH KNITTED CUFF	`I001444OTM`	`06976128075333`	10	On the market
ISOLATION GOWN PPPE 40 WITH KNITTED CUFF	ISOLATION GOWN PPPE 40 WITH KNITTED CUFF	`I001443OTM`	`06976128075326`	10	On the market
ISOLATION GOWN PPPE 40 WITH KNITTED CUFF	ISOLATION GOWN PPPE 40 WITH KNITTED CUFF	`I001238OTM`	`06976128075135`	10	On the market
ISOLATION GOWN PPPE 40 WITH KNITTED CUFF	ISOLATION GOWN PPPE 40 WITH KNITTED CUFF	`I001441OTM`	`06976128075425`	10	On the market
ISOLATION GOWN PPPE 40 WITH KNITTED CUFF	ISOLATION GOWN PPPE 40 WITH KNITTED CUFF	`I001438OTM`	`06976128075395`	10	On the market

Product	Trade name	Reference / catalog number	Primary DI The Primary DI is the main UDI-DI a manufacturer designates as the principal identifier for a device in EUDAMED. View in glossary →	Quantity	Status
Isolation gown	Isolation gown	`I001048OTM`	`06976128075005`	10	On the market
ISOLATION GOWN PPPE 40 WITH KITTED CUFF	ISOLATION GOWN PPPE 40 WITH KITTED CUFF	`I001236OTM`	`06976128075111`	10	On the market
ISOLATION GOWN PPPE 40 WITH KNITTED CUFF	ISOLATION GOWN PPPE 40 WITH KNITTED CUFF	`I001235OTM`	`06976128075104`	10	On the market
ISOLATION GOWN PPPE 40 WITH KNITTED CUFF	ISOLATION GOWN PPPE 40 WITH KNITTED CUFF	`I001171OTM`	`06976128075036`	10	On the market
ISOLATION GOWN PPPE 40 WITH KNITTED CUFF	ISOLATION GOWN PPPE 40 WITH KNITTED CUFF	`I001442OTM`	`06976128075319`	10	On the market
ISOLATION GOWN PPPE 40 WITH KNITTED CUFF	ISOLATION GOWN PPPE 40 WITH KNITTED CUFF	`I001105OTM`	`06976128075050`	10	On the market
ISOLATION GOWN PPPE 40 WITH KNITTED CUFF	ISOLATION GOWN PPPE 40 WITH KNITTED CUFF	`I001175OTM`	`06976128075074`	10	On the market
ISOLATION GOWN PPPE 40 WITH KNITTED CUFF	ISOLATION GOWN PPPE 40 WITH KNITTED CUFF	`I001440OTM`	`06976128075418`	10	On the market
ISOLATION GOWN PPPE 40 WITH KNITTED CUFF	ISOLATION GOWN PPPE 40 WITH KNITTED CUFF	`I001237OTM`	`06976128075128`	10	On the market
ISOLATION GOWN PPPE 40 WITH KNITTED CUFF	ISOLATION GOWN PPPE 40 WITH KNITTED CUFF	`I001174OTM`	`06976128075067`	10	On the market
ISOLATION GOWN PPPE 40 WITH KNITTED CUFF	ISOLATION GOWN PPPE 40 WITH KNITTED CUFF	`I001437OTM`	`06976128075388`	10	On the market
ISOLATION GOWN PPPE 40 WITH KNITTED CUFF	ISOLATION GOWN PPPE 40 WITH KNITTED CUFF	`I001240OTM`	`06976128075159`	10	On the market
ISOLATION GOWN PPPE 40 WITH KNITTED CUFF	ISOLATION GOWN PPPE 40 WITH KNITTED CUFF	`I001439OTM`	`06976128075401`	10	On the market
ISOLATION GOWN PPPE 40 WITH KNITTED CUFF	ISOLATION GOWN PPPE 40 WITH KNITTED CUFF	`I001445OTM`	`06976128075340`	10	On the market
ISOLATION GOWN PPPE 40 WITH KNITTED CUFF	ISOLATION GOWN PPPE 40 WITH KNITTED CUFF	`I001446OTM`	`06976128075357`	10	On the market
ISOLATION GOWN PPPE 40 WITH KNITTED CUFF	ISOLATION GOWN PPPE 40 WITH KNITTED CUFF	`I001173OTM`	`06976128075043`	10	On the market
ISOLATION GOWN PPPE 40 WITH KNITTED CUFF	ISOLATION GOWN PPPE 40 WITH KNITTED CUFF	`I001239OTM`	`06976128075142`	10	On the market
ISOLATION GOWN PPPE 40 WITH KNITTED CUFF	ISOLATION GOWN PPPE 40 WITH KNITTED CUFF	`I001176OTM`	`06976128075081`	10	On the market
ISOLATION GOWN PPPE 40 WITH KNITTED CUFF	ISOLATION GOWN PPPE 40 WITH KNITTED CUFF	`I001436OTM`	`06976128075371`	10	On the market
ISOLATION GOWN PPPE 40 WITH KNITTED CUFF	ISOLATION GOWN PPPE 40 WITH KNITTED CUFF	`I001447OTM`	`06976128075364`	10	On the market
ISOLATION GOWN PPPE 40 WITH KNITTED CUFF	ISOLATION GOWN PPPE 40 WITH KNITTED CUFF	`I001444OTM`	`06976128075333`	10	On the market
ISOLATION GOWN PPPE 40 WITH KNITTED CUFF	ISOLATION GOWN PPPE 40 WITH KNITTED CUFF	`I001443OTM`	`06976128075326`	10	On the market
ISOLATION GOWN PPPE 40 WITH KNITTED CUFF	ISOLATION GOWN PPPE 40 WITH KNITTED CUFF	`I001238OTM`	`06976128075135`	10	On the market
ISOLATION GOWN PPPE 40 WITH KNITTED CUFF	ISOLATION GOWN PPPE 40 WITH KNITTED CUFF	`I001441OTM`	`06976128075425`	10	On the market
ISOLATION GOWN PPPE 40 WITH KNITTED CUFF	ISOLATION GOWN PPPE 40 WITH KNITTED CUFF	`I001438OTM`	`06976128075395`	10	On the market

Isolation gown for single use

Device family identification

Classification

Device characteristics

References by status

Manufacturer & authorised representative

Manufacturer

Authorised representative

Device family identification

Classification

Device characteristics

EMDN code(s)

References by status

Manufacturer & authorised representative

Manufacturer

Authorised representative

References

EMDN code(s)

References